Clinical Research Associate Jobs in Centreville, VA

VLP Therapeutics is seeking a professional to support financial tracking, budget management, and contract oversight for clinical trials. This role involves managing clinical trial budgets, ensuring compliance with financial regulations, negotiating contracts, overseeing vendor payments and monitoring vendor performance to ensure cost-effective and timely delivery of services. Essential Job Functions Financial Tracking and Reporting Track and report on clinical trial budgets, burn rates, and expenditures. Collaborate with finance teams to ensure accuracy and compliance in cost forecasts and reporting. Monitor CRO and site invoicing to ensure payments align with contractual terms and project milestones. Oversee the management of clinical grants related to budgeting, disbursements, and financial tracking. Contracts Management, Purchase Orders (POs) and Invoice Management Manage the lifecycle of clinical trial agreements (CTAs) and related contracts, including negotiation, execution, and amendment. Ensure timely and accurate contract deliverables and payments. Manage the issuance of POs for clinical trial activities. Ensuring accurate tracking of spending. Review, approve, and track invoices related to trial activities, ensuring timely payment processing in compliance with financial controls. Vendor Management Oversee and manage the deliverables of CROs and other external vendors to ensure compliance with timelines, quality standards, and regulatory requirements. User performance metrics to regularly review CRO performance and implement corrective actions when necessary. Build and maintain strong relationships with vendors, manufacturers, and service providers. Audit Preparation and Compliance Prepare for internal and external audits from regulatory authorities (e.g., FDA, EMA). Maintain documentation (e.g., trial master files) to ensure audit readiness. Ensure procurement and CRO service activities comply with relevant regulations (e.g., FDA, GxP, ICH guidelines). Procurement and Sourcing Source and procure clinical trial services such as clinical trial insurance, CRO services, and lab services. Optimize sourcing strategies to align with budget constraints while maintaining quality. Manage logistics to ensure samples are delivered on time and with appropriate services conducted. Monitor and control procurement budgets, identifying cost-saving opportunities without compromising quality. Qualifications Bachelor's degree in supply chain management, business administration, or a related field. Experience in clinical trial management or procurement is a plus. Proficiency in leveraging financial tracking tools and databases to manage budgets, POs, and invoicing. Preferred Qualifications 5+ years of experience in clinical trial management, procurement, or supply chain management is preferred. Strong knowledge of GCP, ICH guidelines, and clinical trial processes. Strong understanding of financial regulations, grant management, and cost tracking in clinical research. Supervision None Working Environment Location: Gaithersburg, MD. Onsite. Physical Requirements While performing the duties of the job, the employee is occasionally required to stand, sit, walk, reach, stretch, and manual dexterity. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. While performing the duties of this job, the employee may be asked to lift objects up to 20 lbs. Equal Employment Opportunity (EEO) VLP is an equal opportunity employer. We are committed to providing an inclusive and welcoming environment for all members of our team, partners, and members. We do not discriminate on the basis of race, color, religion, gender, gender expression, age, national origin, disability, marital status, sexual orientation, or military status.

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.

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

Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented Biology or related fields expert to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD. Rates vary based on expertise, skills assessment, location, project need, and other factors. For example, higher rates may be offered to PhDs. For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project.

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. ***************************************************** 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.

Piper Health & Sciences is seeking an entry level Clinical Research Assistant (Regulatory) to join a clinical research company in the Bethesda, MD area. This is an exciting opportunity to gain clinical regulatory experience across multiple therapeutic areas! Responsibilities for the Clinical Research Assistant include: * Prepare standard documentation supporting regulatory filings and distribution to stakeholders. * Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. * Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate. * Draft, edit, and distribute various documents as needed based on templates and work instructions. * Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc. * Track regulatory activity, maintain, and update databases, and ensure that records are complete and current. * Provide other administrative regulatory support as needed. Qualifications for the Clinical Research Assistant include: * 0-1+ years of clinical research or regulatory experience at a CRO, sponsor, or academic site/institution. * Familiarity with Good Clinical Practices (GCP) and/or experience of working in an FDA-regulated environment is desirable. * Proficiency in MS Office (Word, Excel, and Outlook) and experience with SharePoint is preferred. * Bachelor's degree in Clinical Research, Regulatory Affairs, Public Health, or related field is required. Compensation for the Clinical Research Assistant includes: * Salary range: approximately $55,000 - $60,000 annually, commensurate with experience * Comprehensive Benefits: Cigna Medical, Dental, Vision, 401k, STD, LTD, Paid sick leave as required by law, Hybrid working schedule This job opens for applications on 3/4/2025. Applications will be accepted at least 30 days from the posting date. Clinical research, clinical trials, oncology, infectious disease, hiv/aids, solid tumor, cancer, regulatory affairs, regulatory operations, reg ops, fda, food and drug administration, ich, gcp, good clinical practices, cro, biotechnology, pharmaceutical, drug development, vaccine development, entry level clinical research #LI-CP1 #LI-HYBRID

What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position Overview The Travel Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. What You'll Be Working On This role will perform a variety of clinical and administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. This role will be based in Washington, D.C. with local and national travel to clinical events or site locations. Duties include but not limited to: ● Ability to understand and follow institutional SOPs. ● Participate in recruitment and pre-screening events (may be multiple locations). ● Assist with preparation of outreach materials. ● Identify potential participants by reviewing medical records, study charts and subject database. ● Assist with recruitment of new participants by conducting phone screenings. ● Request medical records of potential and current research participants. ● Schedule visits with participants, contact with reminders. ● Obtain informed consent per Care Access Research SOP, under the direction of the Clinical Research Coordinator (CRC). ● Complete visit procedures as required by protocol, under the direction of the CRC. ● Collect, process and ship specimens as directed by protocol, under the direction of the CRC. ● Record data legibly and enter in real time on paper or e-source documents. ● Request study participant payments. ● Update all applicable internal trackers and online recruitment systems. ● Assist with query resolution. ● Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. ● Assist with maintaining all site logs. ● Assist with inventory and ordering equipment and supplies. ● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. ● Maintain effective relationships with study participants and other care Access Research personnel. ● Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. ● Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Physical and Travel Requirements This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide, US based. Duties may require travel in the following models: ● Two weeks on / One week off deployments ● Temporary Event Support (3-7-day deployment durations) ● Weekly deployments (one week on, 2-5 days off). ● Frequency and length of travel may depend on the length and location of study, site, and event. ● Deployments normalize to a 32 to 42-hour work week on average. What You Bring Knowledge, Skills, and Abilities: ● Ability and willingness to work independently with minimal supervision. ● Ability to learn to work in a fast-paced environment. ● Excellent communication skills and a high degree of professionalism with all types of people ● Excellent organizational skills with strong attention to detail ● A working knowledge of medical and research terminology ● A working knowledge of federal regulations, Good Clinical Practices (GCP) ● Critical thinker and problem solver ● Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. ● Contribute to team and site goals. ● Proficiency in Microsoft Office Suite ● High level of self-motivation and energy ● An optimistic, "can do" attitude. Certifications/Licenses, Education, and Experience: ● A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. ● Phlebotomy experience and proficiency required. ● Some Clinical Research experience preferred. Benefits (Employment Contract - Full Time) ● PTO/vacation days, sick days, holidays. ● 100% paid medical, dental, and vision Insurance. 75% for dependents. ● HSA plan ● Short-term disability, long-term disability, and life Insurance. ● Culture of growth and equality (US Full-Time Employees Only) ● PTO/vacation days, sick days, holidays. ● 100% paid medical, dental, and vision Insurance. 75% for dependents. ● HSA plan ● Short-term disability, long-term disability, and life Insurance. ● Culture of growth and equality Diversity & Inclusion We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is currently unable to sponsor work visas. Employment Statement Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Minimum Education Bachelor's Degree BA/BS degree in a science, technical, health-related field or another applicable discipline. (Required) Or Minimum Work Experience 0 years Experience working in a medical or scientific research setting (Preferred) We are specifically looking for candidates with the following qualifications: Strong analytical, verbal and written communication skills Organizational skills with attention to detail Ability to work closely with a diverse team including stakeholders, investigators, and research staff Ability to work both independently and collaboratively Commitment to improving healthcare delivery and outcomes Skilled in multi-team coordination and communication Interest in health equity research Preferred Qualifications Quantitative data analysis skills (R Studio, SAS, STATA, SPSS, Python, etc.) Qualitative data analysis skills (NVivo, Dedoose, etc.) Data visualization software experience (Tableau, PowerBI, etc) Proficiency in Spanish 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. 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. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. 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 documenting participant incentive distribution. 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. 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. Completes accurate IRB submissions within institutional timeframes. 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. Data Collection 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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 The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant 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. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. The Addressing Disparities Through Advocacy, Prevention, and Technology (ADAPT) Research Lab led by Dr. Monika Goyal is looking for an enthusiastic and motivated individual for a clinical research assistant position. This position will provide support to several ongoing studies to address inequities in emergency care. The successful candidate will bring a passion for the work and will support the day-to-day operations of the study, including administrative duties, screening, enrollment, and recruitment of research participants, data collection, and data management. Candidate will be expected to code quantitative data using their preferred program and analyze results. The research assistant will work as part of a highly collaborative team dedicated to improving care in the emergency department.

Minimum Education Bachelor's Degree BA/BS degree in a science, technical, health-related field or another applicable discipline. (Required) Minimum Work Experience 0 years Experience working in a medical or scientific research setting (Preferred) 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. 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. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. 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 documenting participant incentive distribution. 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. 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. Completes accurate IRB submissions within institutional timeframes. 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. Data Collection 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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

Title: Clinical Research Assistant Report to: Lead Ophthalmic Technician & Physicians Schedule: Monday-Friday FLSA status: Non-exempt/Hourly NVOA is a busy high-quality practice with 18 doctors and three locations in Falls Church, Fairfax, and Alexandria. We are seeking a Clinical Research Assistant to join our team. Responsibilities: Assist with the administration and execution of clinical research trials. Review and clean data, assist with identifying discrepancies and resolve issues. Takes patient history and conducts visual acuity screenings. Prepares patients for exams and procedures. Takes measurements and documents exam results. Collaborate with the clinical team to ensure proper data is collected and proper procedures are followed. Monitor the recruitment and enrollment of study participants. Communicate with relevant team members to resolve issues and ensure smooth trial operations. Maintain accurate and up-to-date trial documentation. Assist with the analysis and evaluation of clinical data gathered during research. Other duties as needed. Qualifications: 1-2 years of experience as an ophthalmic technician. Bachelor's degree in healthcare or relevant major is highly desirable. 1-2 years of experience in clinical data management and clinical research. Attention to detail and strong written & verbal communication skills. Knowledge in JCAHO standards Experience in Clinical Trial Management Software

Title: Clinical Research Assistant Report to: Lead Ophthalmic Technician & Physicians Schedule: Monday-Friday FLSA status: Non-exempt/Hourly NVOA is a busy high-quality practice with 18 doctors and three locations in Falls Church, Fairfax, and Alexandria. We are seeking a Clinical Research Assistant to join our team. Responsibilities: Assist with the administration and execution of clinical research trials. Review and clean data, assist with identifying discrepancies and resolve issues. Takes patient history and conducts visual acuity screenings. Prepares patients for exams and procedures. Takes measurements and documents exam results. Collaborate with the clinical team to ensure proper data is collected and proper procedures are followed. Monitor the recruitment and enrollment of study participants. Communicate with relevant team members to resolve issues and ensure smooth trial operations. Maintain accurate and up-to-date trial documentation. Assist with the analysis and evaluation of clinical data gathered during research. Other duties as needed. Qualifications: 1-2 years of experience as an ophthalmic technician. Bachelor's degree in healthcare or relevant major is highly desirable. 1-2 years of experience in clinical data management and clinical research. Attention to detail and strong written & verbal communication skills. Knowledge in JCAHO standards Experience in Clinical Trial Management Software

Overview Join the HJF Team! HJF is seeking a Clinical Research Assistant to perform data collection by conducting research interviews in support of National Guard Programs, including Integrated Primary Prevention and Behavioral Health Programs, and support program education and training efforts. The Clinical Research Assistant will recruit and screen subjects for research studies and collects baseline and follow up data from subjects. This is the first of four levels of clinical research assistants and works under the guidance and direction of senior staff. This position will be in support of the Department of Psychiatry / Center for the Study of Traumatic Stress and, in particular, National Guard Programs (NGP), including Army National Guard (ARNG) Behavioral Health (BH) and Integrated Primary Prevention. The 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 humanmade 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 as: www. cstsonline. org. The Department has active research programs in the Basic and Clinical Sciences and Neurosciences. In addition to intramural research projects, the Department of 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 the 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. Note: This site requires that the incumbent has lived in the US for three out of the past five years. Responsibilities Supports research and/or development in collaboration with others for educational and training projects. Provides technical assistance to the Study Coordinator, Program Managers, and Senior Operations Manager with team meetings, program design, curriculum development, activities, and products Establishes and maintains database files and progress reports for studies, projects and programs. Performs administrative duties such as: assisting in maintaining study database and files as well as scheduling study appointments; assisting in developing and submitting grants, papers and abstracts, manuscripts and presenting studies, developing protocol manuals and data collection instruments; participates in field visits. Assists with the preparation of manuscripts, reports, and presentations including editing and formatting documents. Distributes manuscripts and reports to all scientific collaborators as required. Interaction with study subjects, including screening, recruitment and data collection. 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. Preference for degrees and experience in social sciences and education. Minimum of 0-2 years experience required. Experience with content and visual development preferred (Canva, PPT, Adobe, etc. ). Required Knowledge, Skills and Abilities Ability to understand and utilize scientific terminology and research theory in both oral and written communications. Ability to use measurable and verifiable information for making decisions or judgments; Excellent organizational and project management skills. Ability to obtain and maintain a T1 Public Trust and Common Access Card (CAC). Work Environment This position will take place primarily in an office environment. Up to 10% travel may be required. Compensation The hourly pay range for this position is $18. 25-$23. 00. 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 Assistant - (250000CR) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant 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. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBachelor's Degree BA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) Minimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) 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. 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. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. 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 documenting participant incentive distribution. 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. 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. Completes accurate IRB submissions within institutional timeframes. 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. Data Collection 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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) - FT - Full-TimeShift: DayWork Schedule: 8-4:30Job Posting: Feb 24, 2025, 3:48:59 PMFull-Time Salary Range: 42702.4 - 71156.8

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

What We DoCare Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position OverviewThe Travel Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. What You'll Be Working OnThis role will perform a variety of clinical and administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. This role will be based in Washington, D.C. with local and national travel to clinical events or site locations. Duties include but not limited to:● Ability to understand and follow institutional SOPs. ● Participate in recruitment and pre-screening events (may be multiple locations).● Assist with preparation of outreach materials.● Identify potential participants by reviewing medical records, study charts and subject database.● Assist with recruitment of new participants by conducting phone screenings.● Request medical records of potential and current research participants.● Schedule visits with participants, contact with reminders.● Obtain informed consent per Care Access Research SOP, under the direction of the Clinical Research Coordinator (CRC).● Complete visit procedures as required by protocol, under the direction of the CRC.● Collect, process and ship specimens as directed by protocol, under the direction of the CRC.● Record data legibly and enter in real time on paper or e-source documents. ● Request study participant payments.● Update all applicable internal trackers and online recruitment systems.● Assist with query resolution.● Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. ● Assist with maintaining all site logs. ● Assist with inventory and ordering equipment and supplies. ● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.● Maintain effective relationships with study participants and other care Access Research personnel.● Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management.● Communicate clearly verbally and in writing.Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Physical and Travel Requirements This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide, US based. Duties may require travel in the following models: ● Two weeks on / One week off deployments ● Temporary Event Support (3-7-day deployment durations) ● Weekly deployments (one week on, 2-5 days off). ● Frequency and length of travel may depend on the length and location of study, site, and event. ● Deployments normalize to a 32 to 42-hour work week on average. What You BringKnowledge, Skills, and Abilities:● Ability and willingness to work independently with minimal supervision. ● Ability to learn to work in a fast-paced environment. ● Excellent communication skills and a high degree of professionalism with all types of people● Excellent organizational skills with strong attention to detail ● A working knowledge of medical and research terminology ● A working knowledge of federal regulations, Good Clinical Practices (GCP) ● Critical thinker and problem solver ● Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. ● Contribute to team and site goals. ● Proficiency in Microsoft Office Suite ● High level of self-motivation and energy ● An optimistic, “can do” attitude. Certifications/Licenses, Education, and Experience:● A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. ● Phlebotomy experience and proficiency required.● Some Clinical Research experience preferred. Benefits (Employment Contract - Full Time) ● PTO/vacation days, sick days, holidays. ● 100% paid medical, dental, and vision Insurance. 75% for dependents. ● HSA plan ● Short-term disability, long-term disability, and life Insurance. ● Culture of growth and equality (US Full-Time Employees Only) ● PTO/vacation days, sick days, holidays. ● 100% paid medical, dental, and vision Insurance. 75% for dependents. ● HSA plan ● Short-term disability, long-term disability, and life Insurance. ● Culture of growth and equality Diversity & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is currently unable to sponsor work visas. Employment StatementCare Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

Piper Clinical Solutions is seeking a Clinical Research Assistant in the Bethesda, MD area to support a well-established clinical research organization (CRO) focused on providing biopharmaceutical development support, health information services, and health & environment assessments to commercial and government clients. Responsibilities of the Clinical Research Assistant include: * Assist in overall project support to various clinical research studies, with a specific focus in medical writing * Revise Standard Operating Procedures (SOPs) for ongoing clinical research studies * Assist various departments in Regulatory, Project Management, Data Management, and Clinical Operations * Abstract protocol information into databases in support of clinical trials * Respond to queries regarding clinical research studies associated with protocols and abstractions Requirements of the Clinical Research Assistant include: * Experience with IRB/GCP regulations * Bachelor's Degree in Science related field (Master's preferred) Compensation for the Clinical Research Assistant include: * Salary Range: $45,000 - $55,000 annually, commensurate with experience * Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave as required by law, hybrid flexibility This job opens for applications on 02/14/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, gcp, good clinical practices, qms, quality management system, quality management plans, cqms, sop, standard operating procedures, protocol, quality assurance, qa, capa, MPH, master of science, MS, physiology, pharmacology, biotechnology, pharmaceutical, clinical research, epidemiology, biostats, medical writer, clinical research assistant, clinical research associate, CRA, CTA, clinical trial assistant, research associate, research assistant, research, REDCap, medidata, RAVE, EDC, electronic data capture, CTMS, clinical trial management system, IRB, institutional review board, clinical trials, publication, research project, medical scribe, medical assistant, meeting minutes, SOP, standard operating procedure, science writing, science writer #LI-BN1 #LI-HYBRID

Minimum Education Bachelor's Degree BA/BS degree in a science, technical, health-related field or another applicable discipline. (Required) Or Minimum Work Experience 0 years Experience working in a medical or scientific research setting (Preferred) 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. 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. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. 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 documenting participant incentive distribution. 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. 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. Completes accurate IRB submissions within institutional timeframes. 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. Data Collection 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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

Overview Join the HJF Team! HJF is seeking a Clinical Research Assistant I to perform research and/or development in collaboration with others for projects. Will perform data collection by conducting research interviews. Provides study project and technical support to senior professional staff. The Clinical Research Assistant will recruit and screen subjects for research studies and collects baseline and follow up data from subjects. This is the first of four levels of clinical research assistants and works under the guidance and direction of senior staff. This position will be in support of the Department of Psychiatry / Center for the Study of Traumatic Stress. 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 Performs research projects, including the collection and organization of data. Follows instructions and standard operating procedures. Independently identifies and collects reports, professional papers, and other relevant information in an organized and proactive capacity. Performs data entry in an accurate, timely, and efficient manner. Maintains clear and accurate data collection and project records, inventories, and logbooks in accordance with Good Clinical and/or Good Laboratory practices. Provides basic data analysis and interpretation. Establishes and maintains database files and progress reports for studies, projects and programs. Performs administrative duties such as: assisting in maintaining study database and files as well as scheduling study appointments; assisting in developing and submitting grants, papers and abstracts, manuscripts and presenting studies, developing protocol manuals and data collection instruments; participates in field visits. Assists with the preparation of manuscripts, reports, and presentations including editing and formatting documents. Distributes manuscripts and reports to all scientific collaborators as required. Interaction with study subjects, including screening, recruitment and data collection. 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. Minimum of 0-2 years experience required. Required Knowledge, Skills and Abilities Knowledge of basic computer programs Ability to follow detailed instructions Excellent written and verbal communication, organizational, and analytical skills Ability to understand and utilize scientific terminology and research theory in both oral and written communications. Ability to use measurable and verifiable information for making decisions or judgments Ability to obtain and maintain a T1/Public Trust background check. Work Environment This position will take place primarily in an office environment. Compensation The hourly pay range for this position is $18. 25-$23. 00. 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 Assistant - (250000BQ) Description The Clinical Research Assistant performs a variety of research, data and clerical duties of a routine and technical nature to support the conduct of clinical research under the direction of a senior research team member. The Research Assistant 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. In this role, the Clinical Research Assistant completes tasks including identifying eligible participants under the supervision of a senior research team member, preparing necessary documents, equipment, supplies, etc. for research visits and conducting and documenting visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies. Qualifications Minimum EducationBachelor's Degree BA/BS degree in a science, technical, health-related field or another applicablediscipline. (Required) OrMinimum Work Experience0 years Experience working in a medical or scientific research setting (Preferred) 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. 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. Participant Enrollment Adheres to the IRB-approved recruitment plan. Identifies participants that meet eligibility requirements under the supervision of a senior research team member. 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. 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 documenting participant incentive distribution. 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. 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. Completes accurate IRB submissions within institutional timeframes. 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. Data Collection 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 and assists in maintaining regulatory documents per sponsor and institutional requirements. 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: Maryland-Silver SpringWork Locations: Inventa Towers 1 Inventa Place Silver Spring 20910Job: ResearchOrganization: Ctr Clinical & Community RsrchPosition Status: R (Regular) - FT - Full-TimeShift: DayWork Schedule: 11a-7pJob Posting: Feb 12, 2025, 1:13:50 PMFull-Time Salary Range: 42702.4 - 71156.8