Manager of Clinical Trials
Clinical Research Coordinator Job In Bethesda, MD
About the Role: The Manager of Clinical Trials will be an integral part of our management service organization, responsible for setting up and overseeing clinical trials across our various clinical locations. This role involves hands-on setup of trials, training, guiding, and overseeing local staff to ensure the successful execution of clinical trials. This role may require some travel, particularly during the initiation and conclusion phases of trials, to support and monitor activities at different locations. The Manager of Clinical Trials will play a key role in maintaining high standards and consistency across all sites, ensuring effective trial management and compliance with regulatory requirements.
What You'll Do: The Manager of Clinical Trials plays a pivotal role in orchestrating the operational aspects of sponsored studies. This position is responsible for setting up and managing clinical trial processes, including implementing the Clinical Trial Management System (CTMS), establishing and overseeing quality management systems at central, site, and study levels, and managing both source documentation and electronic case data (ECD) activities. The Clinical Trials Manager ensures regulatory compliance by handling deviation management, communication with IRBs and sponsors, and coaching the clinical trial staff. Responsibilities also include preparing content for auditable training systems, establishing regulatory document management and risk management programs, and implementing an internal audit-readiness program compatible with BIMO standards. The role requires fostering collaborative relationships with contract resource organizations (CROs), vendors, sponsors, healthcare providers, and patients, with a focus on maintaining high-quality, compliant clinical trial conduct and prioritizing participant safety and well-being.
About Our Team:
We are committed to fostering a close-knit, collaborative environment across both our clinical and operational support teams. Our culture promotes open communication, the sharing of ideas, and a strong sense of camaraderie. Unlike traditional bureaucratic settings, our dynamic environment encourages agility and innovation. If you're eager to take on diverse roles and make a direct impact on our clinic's ability to deliver personalized, patient-centric care, we invite you to join our team! What You'll Need to Get the Job Done:
• Bachelor's degree in life sciences, healthcare, or a related field (B.A./B.S.) required.
• 5 years site-level leadership position in Regulatory aspects of the clinical trials (managing deviations, communication with sponsors and Institutional Review Board (IRB), managing Serious Adverse Reaction (SAR), and Suspected Unexpected Serious Adverse Reaction (SUSAR).
• 3 years' experience with the Food and Drug Administration (FDA), Bioresearch Monitoring (BIMO), and third-party audits, with a proven track record of handling 483 reports.
• Proficient in clinical trial regulations, including 21 CFR, International Council for Harmonization (ICH), Good Clinical Practice (GCP).
• Knowledgeable in Clinical Trial Quality Management, including document management, training logs, development of Standard Operating Procedures (SOPs), deviation monitoring.
• Extensive experience with establishment of quality improvement plans, including root cause analysis, Correct and Prevention Action (CAPA), etc.
• In-depth knowledge of clinical trial environment, including its terminology, conventions, and advanced familiarity with site operations and networks.
• Proficient in Project Management, including planning, execution, and monitoring to ensure successful project outcomes.
• Detail-oriented and skilled in building and optimizing systems to enhance efficiency and accuracy.
• Fluency in reading oncology protocols.
• Outstanding communication, both oral and written in business, regulatory and operational contexts.
• Mastery in operation design, including translating study protocols into actionable processes for staff implementation.
• Possess strong coaching skills to motivate clinical trial staff, foster growth, and enhance performance.
• Ability to travel for site visits, sponsor meetings, and conferences.
• Flexibility to work outside standard business hours when necessary.
What Will Make You Great at this Job:
To excel as the Manager of Clinical Trials, you'll need a proactive and can-do attitude. Your hands-on approach will be crucial in setting up and managing trials, and you should be prepared to tackle a variety of tasks typical of a dynamic start-up environment. Your ability to create, document, and implement scalable processes will ensure smooth operations across all our locations. Clear communication skills and a genuine, empathetic approach towards patients will help in fostering a compassionate and supportive environment.
Senior Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
We are seeking a full-time (1.0 FTE) Clinical Research Coordinator in the laboratory of Dr. Tucker (Louise C.) Pyle, at the Children's National Hospital, Washington, DC. The clinical research coordinator will assist with all aspects of a translational research program in genomics and sex characteristics.
Our group is located within the Center for Genomic Medicine, in the vibrant well-resourced Children's National Hospital research community. We focus on genetic causes of rare inborn birth variations of sex characteristics. Specifically, we are interested in the biology of germ cells and the genetics of pediatric germ cell tumor.
Responsibilities
REDCap database creation and management; subject recruitment, consent, data collection, and sample collection; organizing, scheduling, and record-keeping team meetings; IRB protocol maintenance; communication and coordination with teammates and collaborators across campus and beyond. Additional responsibilities include basic data analysis and preparation of manuscripts, grant submissions, and presentations based on the research project and its findings. This role will require direct interaction with patients and families in the clinical setting, direct interaction with teammates in the research laboratory, and offer access to teammates filling these roles for related projects around campus. Skill working with vulnerable populations and/or sex minority communities a plus. Familiarity with REDCap, electronic health records, experience with data analysis, skills in using Excel, SPSS, or other statistical programs, and previous experience with basic laboratory techniques are desirable. Role title, seniority, and opportunity to supervise others will be commensurate with job experience.
Qualifications
Open to CRC or Senior CRC applicants.
Minimum experience two years in a CRC or clinical / research environment.
Clinical Coordinator - (RN), Medical Surgical Unit
Clinical Research Coordinator Job In Rockville, MD
The Clinical Coordinator is a professional leader who serves in a blended role of leadership and bedside nurse. The Clinical Coordinator is responsible for the assessment, coordination, implementation and evaluation of the delivery of safe and effective patient care. The Clinical Coordinator will work together with the Nurse Manager to facilitate, mentor and evaluate others to grow professionally and advance their knowledge and skills. In addition, the Clinical Coordinator will continuously assess unit needs to ensure adequate resources for current and upcoming shifts by collaborating with the Nurse Manager, other departments clinical and nonclinical, to coordinate admissions, transfers, and discharges of patients. The Clinical Coordinator will be prepared to assume the duties of the Nurse Manager in her/his absence. The Clinical Coordinator will hold team members accountable by ensuring adherence to appropriate federal, state and local regulations, Professional Standards, hospital policies, procedures andguidelines.
Qualifications
Minimum Education Requirements
Bachelor of Science degree from a College of Nursing is required if hired on or after July 1, 2018; Master's from a College of Nursing is preferred.
Professional Certification is required (If the individual does not have a Professional Certification upon hire or transfer, one must be obtained within 18 months of the date of hire or advancement into the position).
The individual must be in a Senior Clinical Nurse I or Senior Clinical Nurse II position to apply (internal candidate).
If the candidate is external to the organization, they will have 18 months to advance to the SCNI or SCNII position from the date of hire into the Clinical Coordinator position.
Three to five years bedside nursing experience is required.
Qualifications
American Heart Association (AHA) BLS required upon hire
Must meet all unit specific certification requirements: (PALS, ACLS, NRP)
BS from a College of Nursing
Professional Certification preferred
Must maintain .60 FTE or greater
Ability to learn and use computer systems in order to manage patient information
Demonstrated effective interpersonal, verbal and written communication skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Compensation:
Pay Range:$39.00 - $51.89
Other Compensation (if applicable):
Review the 2024-2025 UMMS Benefits Guide
PandoLogic. Category:Healthcare, Keywords:Clinical Services Coordinator, Location:Rockville, MD-20848
Clinical Research Associate - Oncology - Southeast
Clinical Research Coordinator Job In Washington, DC
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel
+ Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team
+ Acts as Lead SM-training other SMs on study
+ Develops site start up documents for studies including SIV agenda
+ Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines)
+ Represents LTMs or SMs on SMTs/meetings
+ Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
+ Supports country budget development and/or contract negotiation in liaison with CCS colleagues
+ Assists with ASV
+ Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
+ Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
+ Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
**What do you need to have?**
+ Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
+ Must be located in either DC, FL, GA, MD, NC, SC, or VA near a major airport
+ Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
+ Have a minimum of 1-3 years' experience monitoring Oncology trials
+ Knowledge of several therapeutic areas
+ Analytical/risk-based monitoring experience is an asset
+ Ability to actively drive patient recruitment strategies at assigned sites
+ Ability to partner closely with investigator and site staff to meet all of our study timelines
+ Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
+ Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
+ Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
+ Need to travel up to 50%
+ To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff “for fit” makes significant contributions to Howard University's overall mission.
BASIC FUNCTION:
Provide organizational planning and data management of research programs and/or projects conducted in the department and oversee the daily operation of the research laboratory.
SUPERVISORY ACCOUNTABILITY:
Responsible for orienting and training others and assigning and reviewing their work. May also be responsible for acting in a “lead” or “senior” capacity over other positions performing essentially the same work, or related technical tasks and reporting to a higher level on a formal basis.
NATURE AND SCOPE: Internal contacts generally include administrators, faculty, students and staff. External contacts generally include vendors, consultants, visitors and the general public.
PRINCIPAL ACCOUNTABITIES:
Designs and develops standard operating procedures for research programs and/or projects conducted in the laboratory and maintains manual of laboratory operations for quality control and quality assurance.
Designs and maintains secure electronic data files for core and collaborative research conducted in the laboratory.
Works in conjunction with senior research associate for laboratory operation and research training to develop, implement, and evaluate academic core program in molecular genomics.
Assists director in the preparation of research proposals, grant applications, manuscripts, progress reports, and related documents.
Interfaces directly with department's core personnel to enhance, facilitate, and trouble-shoot research programs in the laboratory.
In close consultation with the co-investigators maintains and ensures the integrity of the research data.
Orders equipment and research supplies. Performs other related duties as assigned.
CORE COMPETENCIES:
Skilled in developing research laboratory protocols and the ability to design research plans and conduct laboratory procedures; Ability to work independently and as part of a team.
Experience interfacing with genetic researchers and physicians.
Competence in both oral and written English and interpersonal communication skills.
Skilled in the use of PC computer/software and management of large data files and effective electronic communication within and outside of the department and Howard University.
Ability to communicate effectively orally and in writing with a diverse population.
Must be detailed oriented and organized.
Ability to exercise discretion and ensure a high-level of confidentiality.
Ability to establish and maintain effective and harmonious work relations with faculty, staff, residents, students and the general public.
MINIMUM REQUIREMENTS:
Bachelor's degree in business or administration and 1-3 years of experience. 8 years of related work experience may be substituted in lieu of educational qualifications.
Study Coordinator I
Clinical Research Coordinator Job In Gaithersburg, MD
Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.
Smithers PDS is seeking a Study Coordinator I to join our team in Gaithersburg, MD. This role assists in performing study-related critical activities with supervision/oversight from the Project Manager and department management. Primary activities include: (1) performing quality review of data tables, reports and all study supporting documentation for accuracy and adherence to SOPs, GLP guidelines, and established laboratory policies and (2) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager.
This position is an entry-level professional role. It is paid on a salary basis and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated.
Salary for range for this position is $50,000 - $65,0000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.
Primary Responsibilities
Review run folders, notebooks and other study-related materials and document deviations from SOPs, regulations and/or client specifications.
Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate.
Assure that all run folders and data tables move through the internal process, including the Quality Assurance department, in sufficient time to meet client timelines.
QC review data summary tables from Watson LIMS and various Excel spreadsheet formats.
Organize and maintain project data so it can be submitted for audit or archive in a timely manner
Attend client conference calls and prepare/provide agenda and meeting minutes when required.
Other duties as assigned.
Additional Requirements:
Knowledge of GLP.
Ability to multi-task and participate in multiple studies concurrently.
Ability to ensure high quality data while working under the pressure of strict deadlines.
Overtime and weekend work as required.
Work may require the use of PPE (personal protective equipment).
Corporate Responsibilities:
Adherence to laboratory health and safety procedures.
Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.
Adherence to federal and/or local regulations, as applicable.
Qualifications:
Minimum of an associate degree in Biological Sciences or equivalent experience preferred.
Prior experience reviewing data in detail and identifying errors.
Experience in an analytical laboratory. GLP/GCP Immunochemistry environment is preferred, but not required.
Extremely strong competence using Microsoft Word and Excel especially with various formatting features.
Must be detail-oriented, and well organized with exceptional written and oral communication skills.
Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity, and cell-based assays).
#PharmaJobs
#LI-MV1
Clinical Research Coordinator, Cardiology
Clinical Research Coordinator Job In Washington, DC
The Clinical Research Coordinator will play a key role in coordinating all clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include GCP proficiency, logical thinking, the ability to prioritize, a can-do attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. Looking for candidates who are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. The Clinical Research Coordinator supports research projects in an assigned Practice Area through the performance of basic clinical and administrative procedures including data collection and tracking. This position helps ensure that GWMFA research projects conform to regulatory and clinical guidelines.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
* Monitor key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files), providing timely and quality updates.
* Adhere to IRB-approved research protocols.
* Coordinate and schedule protocol-related research procedures, study visits, and testing with other departments.
* Maintain study source documents.
* Educate participants and family on protocol, study intervention, study vaccine/drug, etc.
Minimum Qualifications
Education
* This position requires the completion of a 4-year college education.
* Medical Assistant/BS/BA in Life Science or related discipline preferred.
Experience
* A minimum of 2 years of experience in clinical research preferred.
Physical Requirements
* Walk, bend, twist, and reach above the shoulder frequently in a clinical setting.
* Must be able to occasionally lift or carry and frequently push or pull up to 20 lbs. as part of the role
* Regularly exposed to healthcare settings that may require personal protective equipment
* Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment.
About GW MFA
MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.
The GW MFA's leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.
Equal Opportunity Employer
The GW Medical Faculty Associates is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.
Study Coordinator I
Clinical Research Coordinator Job In Bethesda, MD
Overview Join the HJF Team! HJF is seeking a Study Coordinator I (Education and Training) to oversee project activities in collaboration with other scientific and technical staff. Under the supervision of the Principal Investigator, the candidate oversees the day-to-day tasks in the execution of the study plan.
The Study Coordinator is expected to engage in some limited travel to the off site locations in order to meet with community leaders.
This position will be in support of the Department of Psychiatry / Center for the Study of Traumatic Stress and, in particular, the National Guard Program.
The Center for the Study of Traumatic Stress (CSTS) is one of the nation's oldest and most highly regarded, academic-based organizations dedicated to advancing trauma-informed knowledge, leadership and methodologies.
The Center's work addresses a wide scope of trauma exposure from the consequences of combat, operations other than war, terrorism, natural and human made disasters, and public health threats as well as risk and protective factors associated with suicidal behaviors.
CSTS is a part of our nation's federal medical school, Uniformed Services University (USU), and its Department of Psychiatry.
These affiliations represent the Center's history, mission and future directions as a major contributor to our country's understanding of the impact of trauma and the advancement of trauma-informed care.
Learn more about the CSTS.
The Department has active research programs in the Basic and Clinical Sciences and Neurosciences.
In addition to intramural research projects, the Department maintains active research funded by the National Institute of Mental Health, National Institute of Drug Abuse, National Science Foundation, the Department of the Army and the Department of the Air Force.
The department has ongoing collaborations with the Walter Reed Army Institute of Research, is sponsor of the Center for the Study of Traumatic Stress and provides psychiatry residency training through its affiliations with Walter Reed National Military Medical Center, National Naval Medical Center and Malcolm Grow Air Force Medical Center and the National Capital Area Graduate Medical Education Consortium.
The Henry M.
Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine.
We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.
HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities Oversees and coordinates the study's various activities.
Reviews tasks lists; ensures timely completion of project tasks.
Plans, conducts, controls, and communicates investigations under supervision of the program leads.
Communicates regularly with program leads and project administrators in order to facilitate execution of program goals/tasks.
Oversees the writing and editing of project materials such as newsletter, website and other lay publications.
Works closely with Communications and Graphics Departments to ensure publications are completed.
Facilitates communication with CSTS teams and partners to ensure that protocols are submitted in the correct manner.
Collaborates with research assistants and team members to complete tasks.
May perform other duties and responsibilities as assigned or directed by the supervisor.
This may include attendance of and participation in required training for role.
Qualifications Education and Experience Bachelor's Degree in Social Science or related field.
Minimum of 3-5 years experience required.
Required Knowledge, Skills and Abilities Knowledge of project management; well-organized.
Ability to follow detailed instructions.
Ability to handle multiple tasks.
Ability to meet deadlines of projects.
experience with google, MS, CANVA suite is preferred Ability to facilitate communication among supervisors and peers.
Ability to obtain and maintain a T1 Public Trust.
Work Environment This position will take place primarily in a office setting.
Compensation The hourly pay range for this position is $24.
09-$28.
85.
Actual hourly pay will be determined based on experience, education, etc.
Benefits HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Clinical Research Coordinator (DCR)
Clinical Research Coordinator Job In Washington, DC
17191 St Lukes WaySte 100, The Woodlands, Texas, 77384-8043, United States of America
At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.
Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine.
Sound like you? Then you might be a great fit for a Clinical Research Coordinator role with DaVita Clinical Research (DCR)
We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.
This position will be based in our Shenandoah, TX (North Houston) office and coordinate and execute all aspects of late phase clinical trials in Shenandoah (North Houston) surrounding areas. Based on business needs, a flexible weekly work schedule may be available.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out.
Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities.
Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates.
Responsible to deliver or exceed project enrollment targets for clinical research studies at their site.
Responsible for accurate and timely data entry into the electronic data entry systems.
Responsible for timely resolution of all data queries to meet project timelines for database lock.
Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law.
Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry.
Understands and promotes compliance with all applicable healthcare and research regulations.
MINIMUM QUALIFICATIONS
High School Diploma or equivalent is required.
Bachelor's Degree is preferred.
Minimum 1 year of clinical research experience managing studies from start up to close out or equivalent experience.
Reliable transportation to travel between local research sites.
Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.
Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.
Experience in managing confidential information and/or issues using discretion and Judgment
Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred
DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.
What We'll Provide:
More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.
Flexible weekly work schedule: This will vary and is based on current business needs
December Industry wellness break (Week between Christmas and New Year's Day)
Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
Support for you and your family: Family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave and more
Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning.
Here is what you can expect when you join our Village:
• A "community first, company second" culture based on Core Values that really matter.
• Clinical outcomes consistently ranked above the national average.
• Award-winning education and training across multiple career paths to help you reach your potential.
• Performance-based rewards based on stellar individual and team contributions.
• A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
• Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.
Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."
Why wait? Explore a career with DaVita today.
Go to ************************* to learn more or apply
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position is remote and may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned.
Minimum Education
Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required)
Minimum Work Experience
1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Study Coordinator
Clinical Research Coordinator Job In Washington, DC
4 Bradley Park DrSte 2b, Columbus, Georgia, 31904-3655, United States of America
At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.
Do you love patient care? Are you a LPN or RN, but are tired of the demands of working in a healthcare setting? Have you ever explored using your clinical skills differently? Clinical Research allows a more flexible schedule for healthcare providers interested in a dynamic and fast paced environment that is on the cutting edge of medicine.
Sound like you? Then you might be a great fit for a Clinical Research Study Coordinator role with DaVita Clinical Research (DCR)
We are looking for a highly motivated, positive and innovative Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices. DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.
This position will be based in our Montgomery, AL office and coordinate and execute all aspects of late phase clinical trials in Montgomery and surrounding areas. Based on business needs, a flexible weekly work schedule is available.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Accountable for the successful execution of clinical trials through all phase of the study: enrollment, maintenance and close out.
Responsible for performing research procedures according to the study protocol and working in partnership with the physician investigator to coordinate research activities.
Serves as a liaison between the physicians (Principal Investigator or Sub-Investigator), study sponsors and DaVita facility teammates.
Responsible to deliver or exceed project enrollment targets for clinical research studies at their site.
Responsible for accurate and timely data entry into the electronic data entry systems.
Responsible for timely resolution of all data queries to meet project timelines for database lock.
Demonstrates compliance with good clinical practice (GCP) and applicable law, and verifies that study teams comply with GCP and applicable law.
Demonstrates adherence to DCR standard operating procedures and policies and with the standards customary in the clinical research industry.
Understands and promotes compliance with all applicable healthcare and research regulations.
MINIMUM QUALIFICATIONS
BS/BA preferred.
Minimum 1 year of clinical research experience or equivalent experience.
Reliable transportation to travel between local research sites.
Commitment to and role model of DaVita's values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.
Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through.
Experience in managing confidential information and/or issues using discretion and Judgment
Certified Clinical Research Coordinator (SOCRA or ACRP) - preferred
DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.
What We'll Provide:
More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.
Flexible weekly work schedule: This will vary and is based on current business needs
December Industry wellness break (Week between Christmas and New Year's Day)
Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
Support for you and your family: Family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave and more
Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning.
Here is what you can expect when you join our Village:
• A "community first, company second" culture based on Core Values that really matter.
• Clinical outcomes consistently ranked above the national average.
• Award-winning education and training across multiple career paths to help you reach your potential.
• Performance-based rewards based on stellar individual and team contributions.
• A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
• Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.
Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."
Why wait? Explore a career with DaVita today.
Go to ************************* to learn more or apply
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed Diversity & Belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
Applications are accepted on an ongoing basis.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Coordinator, Cardiology
Clinical Research Coordinator Job In Washington, DC
The Clinical Research Coordinator will play a key role in coordinating all clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include GCP proficiency, logical thinking, the ability to prioritize, a can-do attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills. Looking for candidates who are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. The Clinical Research Coordinator supports research projects in an assigned Practice Area through the performance of basic clinical and administrative procedures including data collection and tracking. This position helps ensure that GWMFA research projects conform to regulatory and clinical guidelines.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.
Monitor key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files), providing timely and quality updates.
Adhere to IRB-approved research protocols.
Coordinate and schedule protocol-related research procedures, study visits, and testing with other departments.
Maintain study source documents.
Educate participants and family on protocol, study intervention, study vaccine/drug, etc.
Minimum Qualifications
Education
This position requires the completion of a 4-year college education.
Medical Assistant/BS/BA in Life Science or related discipline preferred.
Experience
A minimum of 2 years of experience in clinical research preferred.
Physical Requirements
Walk, bend, twist, and reach above the shoulder frequently in a clinical setting.
Must be able to occasionally lift or carry and frequently push or pull up to 20 lbs. as part of the role
Regularly exposed to healthcare settings that may require personal protective equipment
Requires manual dexterity to operate a computer keyboard, calculator, copier machine, and other equipment.
About GW MFA
MFA physicians provide comprehensive patient care, offering one practice for the whole person with 52 medical and surgical specialties. As members of the GW School of Medicine and Health Sciences faculty, MFA providers are teachers and mentors for medical students, residents, fellows, and researchers preserving the rich tradition of academics, research, and healing. In addition to maintaining a closely integrated alliance with The George Washington University and The George Washington University Hospital (GWUH) which is separately owned and operated by Universal Health Services (UHS), the GW MFA has active referring relationships with 12 area hospitals.
The GW MFA's leading healthcare presence in the DC metro region is complemented by a network of community-based practices in DC, Maryland, and Virginia. Given its geographic location in central NW Washington, DC, and proximity to more than 175 resident embassies, the MFA continues to evolve its international clinical outreach.
Equal Opportunity Employer
The GW Medical Faculty Associates is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
Minimum Education Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience 1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC\: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Coordinator
Clinical Research Coordinator Job In Washington, DC
Clinical Research Coordinator - (250000EQ) Description The Clinical Research Coordinator participates in or leads day-to-day operations of clinical research studies conducted by a principal investigator. The Research Coordinator performs a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position is remote and may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant as assigned. Qualifications Minimum EducationBachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline (Required) Minimum Work Experience1 year 1 year of applicable work, research or internship experience (e.g. research assistant, data manager, clinician or other interaction with a research population). (Required) Functional AccountabilitiesResponsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidance (International Counsel on Harmonization) regarding human subjects research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Research Administration
Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
Accurately creates, completes, maintains and organizes study documents.
Accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
Reviews current literature to obtain information relevant to clinical research program, as directed.
Attends study meetings, which could include overnight travel, as requested by principal investigator.
Works well with other members of the research team and seeks and provides input when appropriate.
Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
Participant Enrollment
Employs strategies to recruit and retain research participants, while adhering to the IRB-approved recruitment plan.
Screens subjects for eligibility per the protocol and institutional policies.
Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
Engages participants/LARs in the informed consent process according to institutional policies.
Follows procedures for documentation of study payments and participation incentives.
Study Management
Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.
Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
Collects, prepares, processes, ships and maintains accurate inventory of research specimens, and trains others in performing these tasks.
Suggests improvements to specimen handling processes, when needed.
Authors study documents, including informed consents, protocol-specific source documents and IRB contingency responses.
Registers and records participant visits in the appropriate tracking system.
Anticipates study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
Coordinates, prepares for and responds to routine oversight body visits and audits.
Performs query resolution and assists with addressing and correcting audit findings.
Data Collection
Collects data from patient medical records, interviews, questionnaires, diagnostic tests and other sources.
Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).
Ensures that queries are resolved within sponsor and institutional timelines.
Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
Ensures secure storage of study documents.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Cntr for Cancer_ Blood DsordrsPosition Status: R (Regular) - PT - Part-TimeShift: DayWork Schedule: 8am - 12pmJob Posting: Feb 11, 2025, 3:43:50 PMFull-Time Salary Range: 50252.8 - 83761.6
Clinical Coordinator - (RN), Medical Surgical Unit
Clinical Research Coordinator Job In Silver Spring, MD
The Clinical Coordinator is a professional leader who serves in a blended role of leadership and bedside nurse. The Clinical Coordinator is responsible for the assessment, coordination, implementation and evaluation of the delivery of safe and effective patient care. The Clinical Coordinator will work together with the Nurse Manager to facilitate, mentor and evaluate others to grow professionally and advance their knowledge and skills. In addition, the Clinical Coordinator will continuously assess unit needs to ensure adequate resources for current and upcoming shifts by collaborating with the Nurse Manager, other departments clinical and nonclinical, to coordinate admissions, transfers, and discharges of patients. The Clinical Coordinator will be prepared to assume the duties of the Nurse Manager in her/his absence. The Clinical Coordinator will hold team members accountable by ensuring adherence to appropriate federal, state and local regulations, Professional Standards, hospital policies, procedures andguidelines.
Qualifications
Minimum Education Requirements
Bachelor of Science degree from a College of Nursing is required if hired on or after July 1, 2018; Master's from a College of Nursing is preferred.
Professional Certification is required (If the individual does not have a Professional Certification upon hire or transfer, one must be obtained within 18 months of the date of hire or advancement into the position).
The individual must be in a Senior Clinical Nurse I or Senior Clinical Nurse II position to apply (internal candidate).
If the candidate is external to the organization, they will have 18 months to advance to the SCNI or SCNII position from the date of hire into the Clinical Coordinator position.
Three to five years bedside nursing experience is required.
Qualifications
American Heart Association (AHA) BLS required upon hire
Must meet all unit specific certification requirements: (PALS, ACLS, NRP)
BS from a College of Nursing
Professional Certification preferred
Must maintain .60 FTE or greater
Ability to learn and use computer systems in order to manage patient information
Demonstrated effective interpersonal, verbal and written communication skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Compensation:
Pay Range:$39.00 - $51.89
Other Compensation (if applicable):
Review the 2024-2025 UMMS Benefits Guide
PandoLogic. Category:Healthcare, Keywords:Clinical Services Coordinator, Location:Silver Spring, MD-20904
Clinical Research Protocol Coordinator
Clinical Research Coordinator Job In Washington, DC
Minimum Education Bachelor's Degree In health sciences, clinical research or applicable discipline. Knowledge of the biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred.
(Required)
Master's Degree (Preferred)
Minimum Work Experience
4 years Applicable work (e.g., research, clinical, interaction with study population, program coordination);
Work requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research.
Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required
Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).
Previous experience with investigator-initiated or pharma-sponsored clinical trials required
(Required)
Required Skills/Knowledge
Knowledge in clinical research; familiarity with databases, data collection and analysis, able to manage multiple responsibilities and activities with close attention to detail, effective interpersonal skills and ability to communicate with a diverse group of individuals.
Must have demonstrable proficiency in MS Office Suite - particularly Microsoft Excel.
Must also have advanced database management skills, familiarity with electronic health records, quality improvement experience and excellent oral and written communication skills.
Required Licenses and Certifications
Internal candidates should possess one of the following research certifications\: Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA). .
Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP) .
Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP) .
Certification in Healthcare Research Compliance (CHRC) through the Health Care Compliance Association (HCCA) .
External candidates will be required to obtain a appropriate research certification (e.g., CCRP, CCRC, CCRA or CHRC) within one year of hire .
Functional Accountabilities
Responsible Conduct of Research
Demonstrates consistent adherence to the standards for responsible conduct of research.
Complies with and maintains current documentation of all job-related certifications and training
Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance
Protocol and Regulatory Development
Help with protocol design, study implementation, IND submissions, and IRB submissions with local RB and Federal regulations.
Ensures that clinical research protocols, consent forms, investigator brochures and other clinical research documents to support IND submissions in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and guidelines related to IND Applications for investigational study agents, Informed Consent Documents, and Good Clinical Practice and that data collection plans are consistent with regulatory requirements and the protocol objectives.
Regulatory Filing and Reporting
Help preparing regulatory submissions
Supports the preparation of INDs for submission to the FDA
Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the sponsor's specific timeline
Prepare for sponsor audits.
Work with the clinical research team on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the Cell Therapy Research Program.
Prepare draft documents for senior staff review.
Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.
Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.
Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies
Program Coordination
Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.
Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies
Prepares plans and recommendations for any identified necessary changes.
Quality Assurance
Responsible for preparing protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of the more complex clinical research projects
Analysis
Analyze and prepare performance measures and outcome metrics.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Clinical Research Protocol Coordinator
Clinical Research Coordinator Job In Washington, DC
Clinical Research Protocol Coordinator - (250000O0) Description The Clinical Research Protocol Coordinator provides clinical trials regulatory support for the Center for Cancer and Immunology Research department, including specific groups as assigned. The Clinical Research Protocol Coordinator will work with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, problem reports, including all necessary forms. Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents. Review and ensure that protocols and informed consents meet regulatory requirements and are written in a format compatible with the guidelines. Work with research teams to prepare submissions to the appropriate regulatory bodies (e.g. Institutional Review Board, Data and Safety Monitoring Entity, etc.,). Collaborate with staff on IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Manage, track and coordinate regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closures. Help CRCs to maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. Work with PI and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies as needed. Qualifications Minimum EducationBachelor's Degree In health sciences, clinical research or applicable discipline. Knowledge of the biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred. (Required) Master's Degree (Preferred) Minimum Work Experience4 years Applicable work (e.g., research, clinical, interaction with study population, program coordination);
Work requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research.
Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required
Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).
Previous experience with investigator-initiated or pharma-sponsored clinical trials required (Required) Required Skills/KnowledgeKnowledge in clinical research; familiarity with databases, data collection and analysis, able to manage multiple responsibilities and activities with close attention to detail, effective interpersonal skills and ability to communicate with a diverse group of individuals.Must have demonstrable proficiency in MS Office Suite - particularly Microsoft Excel.Must also have advanced database management skills, familiarity with electronic health records, quality improvement experience and excellent oral and written communication skills.Required Licenses and CertificationsInternal candidates should possess one of the following research certifications: Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA). .Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP) .Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals (ACRP) .Certification in Healthcare Research Compliance (CHRC) through the Health Care Compliance Association (HCCA) .External candidates will be required to obtain a appropriate research certification (e.g., CCRP, CCRC, CCRA or CHRC) within one year of hire .Functional AccountabilitiesResponsible Conduct of Research
Demonstrates consistent adherence to the standards for responsible conduct of research.
Complies with and maintains current documentation of all job-related certifications and training
Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance
Protocol and Regulatory Development
Help with protocol design, study implementation, IND submissions, and IRB submissions with local RB and Federal regulations.
Ensures that clinical research protocols, consent forms, investigator brochures and other clinical research documents to support IND submissions in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and guidelines related to IND Applications for investigational study agents, Informed Consent Documents, and Good Clinical Practice and that data collection plans are consistent with regulatory requirements and the protocol objectives.
Regulatory Filing and Reporting
Help preparing regulatory submissions
Supports the preparation of INDs for submission to the FDA
Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB for approval in accordance with regulatory and/or IRB guidelines and in compliance with the sponsor's specific timeline
Prepare for sponsor audits.
Work with the clinical research team on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the Cell Therapy Research Program.
Prepare draft documents for senior staff review.
Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.
Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.
Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies
Program Coordination
Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities.
Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies
Prepares plans and recommendations for any identified necessary changes.
Quality Assurance
Responsible for preparing protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of the more complex clinical research projects
Analysis
Analyze and prepare performance measures and outcome metrics.
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Primary Location: District of Columbia-WashingtonWork Locations: CN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010Job: ResearchOrganization: Ctr Cancer & Immunology RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 9:00-5:30 PMJob Posting: Mar 3, 2025, 9:11:41 PMFull-Time Salary Range: 59155.2 - 98571.2