Clinical Research Manager II - GI Oncology
Clinical Research Coordinator Job 6 miles from Revere
The Clinical Research Manager (CRM) will work within the GI Oncology clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The CRM, in collaboration with the program's physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program's clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program's clinical research staff. The CRM is responsible for tracking and complying with clinical trial performance benchmarks; e.g. protocol and regulatory compliance, patient safety, staff development & training and financial goals, as defined by Senior Research Leadership and the DFCI Clinical Trials Office (CTO).
This role is a hybrid position requiring 2-3 days onsite per week. The selected candidate may only reside & work remotely within the New England states (ME, VT, NH, MA, CT, RI).
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
CLINICAL TRIAL OPERATIONS
Clinical Research Managers (CRM) are responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
The CRM will collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
The CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
REGULATORY & COMPLIANCE
Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.
Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards.
DATA MANAGEMENT & CLINICAL TRIAL MONITORING
Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance when necessary.
Submits required progress/tracking reports to key stakeholders, when applicable.
STAFF HIRING, SUPERVISION, TRAINING & DEVELOPMENT
Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will develop and agenda, take attendance and document all applicable meetings.
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.
SUPERVISORY RESPONSIBILITIES
Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants.
Bachelor's Degree required, with a minimum of 5+ years of related experience, or Master's Degree with 5 years related experience.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Must be able to perform day to day responsibilities independently with little or no supervision from manager.
Must have very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases.
Must have very proficient knowledge of clinical research local policy and federal regulation.
Must efficiently identify complex regulatory scenarios, independently develops viable solutions to present to supervisor.
Must be very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable.
Must have knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and Oncore applications.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
EEOC Poster
#LI-Hybrid
Senior Clinical Project Manager - Hybrid (Cambridge MA)
Clinical Research Coordinator Job 6 miles from Revere
Senior Clinical Project Manager - Permanent - Cambridge, MA
Proclinical is seeking a Senior Clinical Project Manager to oversee the execution and management of global clinical studies. This position holds a hybrid working model.
Primary Responsibilities:
The successful candidate will be responsible for ensuring that trials are conducted in accordance with Good Clinical Practice (GCP), local regulations, and company standards. This role involves collaborating with various stakeholders to drive study activities, manage budgets, and ensure quality outcomes.
Skills & Requirements:
Bachelor's degree in life sciences or related field.
Experience in clinical research and managing international studies.
Strong leadership and team management skills.
Excellent organizational and communication abilities.
Proficiency in software applications (Word, Excel, PowerPoint).
Understanding of financial tracking and budget management.
Knowledge of pharmaceutical industry regulations and drug development processes.
Fluent in English.
The Senior Clinical Project Manager's responsibilities will be:
Oversee study planning, timelines, and budget management.
Ensure compliance with GCP and regulatory requirements.
Collaborate with Contract Research Organizations (CROs) and service providers.
Develop and maintain study protocols and documentation.
Facilitate communication between internal and external stakeholders.
Support strategic direction and decision-making processes.
Manage study team meetings and ensure effective team communication.
Oversee site selection and feasibility processes.
Ensure timely completion of project milestones and reporting.
Participate in continuous improvement initiatives.
Compensation:
$165,000 to $205,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCR
Clinical Research Associate
Clinical Research Coordinator Job 6 miles from Revere
Clinical Research Associate (CRA) - Erectile Dysfunction (ED) Clinical Trials
Employment Type: Contract
We are seeking an experienced Clinical Research Associate (CRA) with a strong background in erectile dysfunction (ED) clinical trials. The ideal candidate will have direct experience monitoring studies related to ED treatments, ensuring compliance with regulatory guidelines, and supporting high-quality data collection.
Key Responsibilities:
Site Monitoring & Management: Conduct site selection, initiation, routine monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Regulatory Compliance: Ensure adherence to FDA, ICH-GCP, and site-specific regulations.
Data Review & Quality Assurance: Verify case report forms (CRFs), source documents, and electronic trial master files (eTMFs) for accuracy and completeness.
Investigator & Site Support: Provide training and ongoing guidance to site staff on study procedures, protocol adherence, and regulatory compliance.
Issue Identification & Resolution: Address site-level challenges such as patient enrollment, protocol deviations, and data inconsistencies.
Stakeholder Communication: Serve as a key liaison between sponsors, investigators, and internal study teams to ensure seamless study execution.
Qualifications:
Experience: Minimum 3+ years of CRA experience, with at least 1+ year in erectile dysfunction (ED) clinical trials.
Education: Bachelor's degree in life sciences, nursing, or a related field required.
Skills:
Strong knowledge of ICH-GCP guidelines, FDA regulations, and ED-specific study protocols
Excellent site management and monitoring abilities
Ability to work independently and manage multiple sites
Strong communication and problem-solving skills
Travel: Willingness to travel as required for site visits.
Preferred Qualifications:
Experience in urology, men's health, or sexual dysfunction studies.
Prior work with CROs, sponsors, or high-volume research sites.
Certification (e.g., ACRP, SOCRA) is a plus.
Clinical Research Associate 2064742
Clinical Research Coordinator Job 6 miles from Revere
Focus: Oncology
Job Overview: Join our client as the inaugural in-house Clinical Research Associate to oversee quality and patient safety, coordinating with a CRO and facilitating daily study operations.
Primary Job Responsibilities:
Partner with CROs for trial monitoring, maintaining compliance, data accuracy, and site relations.
Perform site visits to ensure protocol compliance and manage essential documentation.
Build relationships with study sites and vendors, and develop monitoring tools for data review.
Assist in audit support, track enrollment, oversee data collection, and collaborate on study goals.
Primary Job Requirements:
Bachelor's degree with 6 years of clinical trials experience
Skilled in managing complex oncology studies with a quality and compliance emphasis.
Solid understanding of ICH/GCP, regulations, and relationship-building with sites/vendors.
Willing to travel 50% and adept with Microsoft Office, EDC, CTMS, and eTMF.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Clinical Research Manager II - 240135
Clinical Research Coordinator Job 6 miles from Revere
Responsibilities:
CLINICAL TRIAL OPERATIONS
Clinical Research Managers (CRM) are responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
The CRM will oversee the processing of protocols through the Institutional Review Board (and other institutions' IRBs) when appropriate. The CRM will collaborate with the Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
The CRM will assist the principal investigator in developing the protocol budget, in collaboration with the Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
The CRM will collaborate with the CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
The CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
REGULATORY & COMPLIANCE
Assumes responsibility for essential document compliance for the entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.
Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per CTO standards.
DATA MANAGEMENT & CLINICAL TRIAL MONITORING
Assumes responsibilities for data management and compliance for the entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
Regularly reports data compliance status to key stakeholders; i.e. PI, study Sponsor, CTO. Implements corrective action to maintain data compliance when necessary.
Submits required progress/tracking reports to key stakeholders, when applicable.
STAFF HIRING, SUPERVISION, TRAINING & DEVELOPMENT
Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meetings. Will develop an agenda, take attendance and document all applicable meetings.
Will communicate all personnel concerns to their immediate supervisor and to HR partner for the appropriate response and follow up.
SUPERVISORY RESPONSIBILITIES
Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Must be able to perform day to day responsibilities independently with little or no supervision from the manager.
Must have very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases.
Must have very proficient knowledge of clinical research, local policy and federal regulation.
Must efficiently identify complex regulatory scenarios, independently develop viable solutions to present to supervisor.
Must be very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable.
Must have knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and Oncore applications.
Qualifications:
Bachelor's Degree required, with a minimum of 5+ years of related experience, or Master's Degree with 5 years related experience.
Senior Clinical Trial Manager
Clinical Research Coordinator Job 6 miles from Revere
***Candidate must be local in order to be in the office 1 day per week!
Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
Responsibilities
(including, but not limited to):
Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans.
Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
May provide technical advice to team members.
Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
Interact with clinical research investigators, Key Opinion Leaders and sites.
Interact with Senior Management to report on progress of milestones.
Oversight of study team and site training
Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
Management of study drug distribution and accountability processes and documentation
Oversight of study start-up, study management, data cleaning, and study closeout activities
Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Qualifications:
BA/BS degree in Health or Life Sciences required, advanced degree preferred
A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Exceptional communication and interpersonal skills
Positive team orientated attitude
Must speak fluent English if it is their second language
Advanced proficiency in Microsoft Office and Microsoft Project
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment
Creative problem solver
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel as needed
The salary range for this position is commensurate with experience
Company offers a comprehensive benefits package including:
C
ompetitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Company for employees and their eligible dependents
Fertility and mental health programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various mental, financial, and proactive physical health programs covered by Company
Senior Clinical Trial Manager
Clinical Research Coordinator Job 12 miles from Revere
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
This role is based in our Waltham, MA headquarters. With a hybrid in office schedule.
Responsibilities
(including, but not limited to):
Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans.
Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
May provide technical advice to team members.
Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
Interact with clinical research investigators, Key Opinion Leaders and sites.
Interact with Senior Management to report on progress of milestones.
Oversight of study team and site training
Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
Management of study drug distribution and accountability processes and documentation
Oversight of study start-up, study management, data cleaning, and study closeout activities
Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
BA/BS degree in Health or Life Sciences required, advanced degree preferred
A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Exceptional communication and interpersonal skills
Positive team orientated attitude
Must speak fluent English if it is their second language
Advanced proficiency in Microsoft Office and Microsoft Project
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment
Creative problem solver
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel as needed
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
· C
ompetitive pay and stock options for all employees
·
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
·
Fertility and mental health programs
·
Short- and long-term disability coverage
·
Life, Travel and AD&D
·
401(k) Company Match with immediate company vest
·
Employee Stock Purchase plan
·
Generous vacation plan and paid company holiday shutdowns
·
Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
Clinical Coordinator (Registered Nurse) - Main Operating Room
Clinical Research Coordinator Job 6 miles from Revere
This Clinical Coordinator will be responsible for:
Leading, mentoring, and developing a high-performing team to ensure quality patient care and a positive work environment.
Providing coaching, feedback, and professional development opportunities to team members to enhance staff skills and career growth.
Creating an inclusive, collaborative, and supportive team culture that promotes engagement, accountability, and continuous learning.
Overseeing daily clinical and administrative operations, including staff scheduling, resource allocation, and facilitating coordination of care/service.
Developing, recommending, and implementing internal standards, policies, and procedures to improve quality and cost-effectiveness of patient care.
Selecting, supervising, and evaluating nursing and clinical support personnel to develop and provide staff education/development programs.
Leading and participating in hospital, departmental, and multidisciplinary programs, committees, and special projects.
Collaborating seamlessly across disciplines, working closely with each member of the team.
To qualify, you must have:
Bachelor's Degree in Nursing and current MA RN license required
Master's Degree in Nursing preferred
Minimum 4 years of nursing experience required
Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, childcare and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
Clinical Trial Manager
Clinical Research Coordinator Job 16 miles from Revere
About Climb:
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include, budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.
At Climb Bio, our team has a knack for seeing what no one else sees-and a drive to achieve results no one expects. We are seeking a self-motivated Clinical Trial Manager to oversee and coordinate all aspects of clinical studies from startup to close out. Reporting to the VP of Clinical Operations this person will play a critical role in enabling Climb to deliver on its mission.
Key Responsibilities:
Serve as the Clinical Operations representative on project teams, with support from senior team members as needed
Apply clinical development and operational expertise to ensure the successful execution of clinical studies
Oversee clinical studies to ensure compliance with corporate and regulatory standards
Additional Responsibilities:
Act as the lead Clinical Operations representative on project teams, collaborating with senior team members as required
Coordinate and manage Clinical Team meetings to support project objectives
Assist senior Clinical Operations team members with the setup and management of clinical studies, ensuring adherence to regulatory and quality standards, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs)
Provide oversight of clinical conduct, drug supply, regulatory submissions, data management, and finalization of clinical study reports.
Collaborate with key stakeholders at Contract Research Organizations (CROs) to manage delegated responsibilities, including clinical execution, drug supply, regulatory compliance, and data management
Support senior team members in tracking clinical expenses and budgets
Maintain and manage clinical trial documentation, ensuring proper filing and organization
Review and provide input on study-related documents generated by CROs
Prepare and deliver accurate, timely reports on clinical trial status for senior leadership (monthly, quarterly, or as needed)
Partner with the Climb Bio Quality Team to ensure compliance with SOPs
Qualifications:
Bachelor's degree
Proven experience in managing clinical trials, ideally with a minimum 5 years' experience across all phases of clinical research
At least 2 years of experience in a small biotech or clinical research organization
In-depth knowledge of clinical research processes, GCP guidelines, and regulatory requirements
Excellent communication and interpersonal skills with a focus on managing external relationships effectively
Proficiency in MS Suite
Ability to travel occasionally (approximately 15%)
Key Competencies:
Strategic planning and organizational skills
Analytical and problem-solving abilities
Ability to work effectively with external partners in a dynamic, fast-paced environment
Attention to detail and commitment to quality
This role has the option of being remote or based out of our office in Wellesley, MA.
Base salary offered may vary depending on individual's skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options.
Qualified candidates are encouraged to forward their resumes to ********************
Climb is a publicly traded company with teams in Boston and Seattle. For more information, please visit climbbio.com.
Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.
Foundation Medical Partners - Clinical Trials Manager - Full Time
Clinical Research Coordinator Job 34 miles from Revere
Who We Are:
Affiliated with Southern New Hampshire Medical Center, Foundation Medical Partners is the second largest multi-specialty group in New Hampshire and serves the greater Nashua community. We encourage the professional growth and development of our employees and are proud of the workplace culture we have developed.
About the Job:
Oversees the overall operation of each investigator site within Foundation Medical Partners. The Clinical Trials Manager acts as a liaison between the investigator site and the Administrative Research Committee for Foundation Medical Partners.
What You'll Do:
Understands each of the operational functions within the trials and prioritizes work activities, evaluates effectiveness, and modifies activities as necessary.
Works with the practice managers and Associate Vice Presidents to ensure site staff has adequate time to conduct the study.
Oversees provider schedules as they relate to clinical trials.
Acts as a liaison between all Research personnel to assure compliance with study requirements.
Ensures that the trials are appropriately staffed.
Prepares, administers, and monitors clinical trial budgets. Independently analyzes variances.
Perform other duties as assigned.
Who You Are:
High School diploma required.
Minimum of five years of related healthcare experience and demonstrated leadership skills required.
Experience in a Clinical Role is preferable.
RN, BSN, or Bachelor's in another discipline preferred.
Epic or EMR experience, is a plus!
Why You'll Love Us:
Flexible day shift hours, no weekends!
Health, dental, prescription, and vision coverage for full-time & part-time employees
Competitive pay
Tuition Reimbursement
403(b) Retirement Savings Plan
Education & Paid training courses for continued career progression
& So much more!
#LAL
Clinic Coordinator
Clinical Research Coordinator Job 12 miles from Revere
Must-Haves:
0-2 years of experience in a fast-paced customer service environment (retail or restaurant)
Excellent verbal and written communication skills
Working knowledge of computers and technology
Plusses:
Bachelor's degree preferred
Day to Day:
A leading cancer research institution is seeking a Clinic Coordinator for its Newton, MA based campus. This coordinator plays a vital role in ensuring seamless operations in oncology. Responsibilities include accurately scheduling complex appointments, monitoring scheduling reports and mailboxes, and maintaining confidentiality of patient information. This role requires strong strategic thinking, adaptability, and multitasking skills. The coordinator delivers exceptional customer service, de-escalates grievances, communicates effectively across leadership levels, and provides patient-friendly information. They ensure compliance with policies, HIPAA regulations, and accreditation standards while actively contributing to quality improvement initiatives and emergency responses.
Clinical Research Scientist
Clinical Research Coordinator Job 10 miles from Revere
Winner of the Best and Brightest Companies to Work for in Boston and in the Nation by the National Association for Business Resources (NABR) for the third consecutive year.
Join Our Team as a Part-time (20 Hours) Clinical Research Scientist
Are you passionate about leveraging data and medical research to drive meaningful change in healthcare? We are seeking a Clinical Research Scientist to join our dynamic Data Science team. In this role, you will conduct medical research, analyze clinical and claims-related healthcare data, and contribute to the development of machine learning algorithms and statistical data analysis to assess SSI/MC eligibility.
Key Responsibilities:
Collect and coordinate data from various sources, including claims, medical records, and lab results.
Support the data science team in identifying relevant datasets and resolving short-term research-related questions.
Conduct statistical analysis and programming on large, complex datasets.
Implement advanced statistical and programming techniques for sophisticated quantitative research.
Identify key business questions or hypotheses for analysis.
Utilize Excel, statistical analysis, and research methodologies to analyze trends and enhance decision-making.
Ensure accuracy and validity of methods and results, working independently with sound judgment.
Conduct online and other research to support data-driven insights.
Collaborate with analysts and data scientists to integrate expanded datasets and query techniques.
Provide medical and clinical insights for the assessment of client members.
Contribute to the evaluation and enhancement of data-driven clinical products.
Educate clients and internal stakeholders from a medical/clinical perspective.
Stay updated with the latest literature, emerging policies, clinical developments, and guidelines.
What We're Looking For:
Bachelor's Degree from a medical school and Public Health background, demonstrating strong analytical and quantitative skills.
1-3 years of relevant analytical experience in healthcare (e.g., health plans, hospitals, medical research organizations).
Strong fluency with Excel and knowledge of statistics.
Familiarity with statistical software (SPSS, SAS, STATA) and Microsoft Office Suite.
Coding familiarity with R, SQL, or Python is a plus.
Experience with data visualization tools (Tableau, Power BI) and dashboarding software.
Strong analytical thinking and problem-solving skills.
Keen attention to detail with the ability to manage multiple projects and deadlines.
Effective verbal, written, and interpersonal communication skills.
Self-driven, results-oriented, and able to thrive in a fast-paced environment.
Why Join Us:
Competitive salary and comprehensive benefits package.
Opportunities for career growth and development within a dynamic organization.
Collaborative and inclusive work environment that values teamwork and innovation.
Flexible work options: Remote or Hybrid.
Our Massachusetts based starting annual salary for this role is 40K. The salary does not reflect total compensation, which includes a base salary, benefits and other options.
EEO Statement:
HFI is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. HFI is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. HFI will not tolerate discrimination or harassment based on any of these characteristics. HFI encourages applicants of all ages.
Clinical Research Associate
Clinical Research Coordinator Job 6 miles from Revere
Clinical Research Associate 2064742Location: Boston, MA (Onsite) Focus: OncologyJob Overview: Join our client as the inaugural in-house Clinical Research Associate to oversee quality and patient safety, coordinating with a CRO and facilitating daily study operations.
Primary Job Responsibilities:Partner with CROs for trial monitoring, maintaining compliance, data accuracy, and site relations.
Perform site visits to ensure protocol compliance and manage essential documentation.
Build relationships with study sites and vendors, and develop monitoring tools for data review.
Assist in audit support, track enrollment, oversee data collection, and collaborate on study goals.
Primary Job Requirements:Bachelors degree with 6 years of clinical trials experience Skilled in managing complex oncology studies with a quality and compliance emphasis.
Solid understanding of ICH/GCP, regulations, and relationship-building with sites/vendors.
Willing to travel 50% and adept with Microsoft Office, EDC, CTMS, and eTMF.
About Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member.
We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information.
Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals.
We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
EEO EmployerApex Systems is an equal opportunity employer.
We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.
Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.
com or ************.
Clinical Research Associate
Clinical Research Coordinator Job 23 miles from Revere
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Summary
Job Description
ROLE
The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
KEY RESPONSABILITIES
Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
Conducts investigational product accountability.
Reviews regulatory binder for required documents.
Works closely with in-house CRAs and data management to resolve queries on discrepant data.
Proactively identifies site issues and develops problem-solving strategies for sites.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Manages and resolves conflicting priorities to deliver on commitments.
Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
Participates in industry and client meetings.
Performs additional duties as assigned.
DESIRED QUALIFICATION & EXPERIENCE
BS/BA from an undergraduate program or equivalent experience
2 years of clinical research experience
TECHNICAL COMPETENCES & SOFT SKILLS
Ability to travel.
Proven ability to be careful, thorough, and detail-oriented.
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment.
Self-starter who thrives in a collaborative, yet less structured team environment
Ability to problem-solve unstructured or ambiguous challenges.
Strong command of English, both written and verbal.
Excellent communication and interpersonal skills with customer service orientation.
Proficient with MS Office Suite, particularly Word and Excel.
Permanent authorization to work in the country where you are applying.
Languages
English
Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences
Contract Type
Regular
Senior Clinical Research Coordinator
Clinical Research Coordinator Job 6 miles from Revere
Site: The General Hospital Corporation At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.
At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.
Job Summary
Under the general direction of the Principal Investigator and Research Nurse Manager, the Sr. Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control.
Facilitates physician initiated trials including protocol development, electronic data capture (EDC) implementation and management, information reporting, and ongoing monitoring of trials. Will ensure all project timelines are met.
Qualifications
Principal Duties and Responsibilities:
* Serves as point person and lead for all assigned clinical trials including supporting other team members in study related activities. Utilizes advanced knowledge of clinical trials to serve as subject matter expert regarding protocols, regulatory compliance and sponsor relations.
* Collaborates with investigators and management to plan, implement, monitor, and coordinate clinical trials and study related activities
* Manages study data, ensuring proper collection methods, data quality, retention by team members.
* Conducts routine and advanced data analysis to identify trends, study direction and action items and for use in regulatory reporting and research publications by the principal investigator. Prepares reports for study sponsors and investigators to outline progress and support new opportunities in the trial or research. Prepares ad hoc reports to keep management abreast of the status of studies and operations.
* Participates in the development, implementation, and revision of study related processes, procedures, tools, and training as necessary to improve trial implementation. In conjunction with investigators and management prepares and monitors study budgets, tracks and reports expenses, submits expenses for payment in a timely manner, ensures expenses meet study targets and resolves variances.
Industry Sponsored Trials:
Coordinates assigned industry trials and ensures study goals are met. Day-to-day study responsibilities include:
* Reviews research subject medical records, abstracts data, completes the case report forms (CRFs), and records the information in the electronic data capture systems (EDC).
* Maintains meticulous records of all study patients and administers protocol specified questionnaires and assessments.
* Responds to queries and data entry in adherence to study-specific timelines.
* Interacts with patients enrolled in the research protocols on a regular basis. This includes ensuring medication compliance in accordance with study/department protocols.
* Attends the study procedure in the OR and/or cath lab/Interventional radiology. This includes collecting study related data, as well as the delivery, tracking, and if needed return, of the investigational devices. Communicates and ensures compliance of the study protocol during the procedure.
* Performs activities to support the operational needs to clinical trials to include collecting and shipping of protocol-related lab samples and devices, ensuring investigational devices are ordered, received and securely tracked and ensuring protocol required imaging is done in accordance with protocol requirements and sent to the appropriate core labs in the specified format.
* Updates and obtains required approval from the MGH OR Products Committee regarding Vascular Surgery Research Devices and provides ongoing clinical trial documentation. Complies with the OR products committee requirements for product tracking.
* Supports administrative needs for each trial, including working with administrative staff to schedule patient protocol screening, study procedure, and follow-up appointments and confirming adequate research documentation is online in Epic. Follows hospital research billing processes and provides hospital billing department with appropriate information to ensure product reimbursement.
Physician Initiated Trials:
* Works with investigators to plan research data design, collection, analysis and reporting.
* Collaborates with study team to define and meet enrollment goals, study procedures and reporting expectations. Works with principal investigators to prepare study reports and papers for publication.
* Participates in the development and execution of non-industry supported study budgets focusing on the data collection, monitoring and analysis requirements.
* Obtains patient study data from medical records, physicians, on-site and off-site clinical information systems, etc.
* Conducts on-line and periodical literature searches.
* In collaboration with investigators and management, provides oversight during study visits and audits. This includes: arranging meetings, preparing associated materials, coordinating team debriefings, and lead follow- up related to action items.
* Coordinates routine data monitoring visits/audits; including electronic medical record access, data entry and corrections, and query resolution. Coordinates and serves as a key resource during FDA audits.
* Serves as a liaison with various entities, including study sponsors, FDA, internal and Partners research resources and the hospital's Institutional Review Board (IRB). Cultivates and maintains effective working relationships to ensure open communication and partnerships that facilitate the division's growing clinical research program. Prepares documents and reports for the IRB including IDE Safety Letters, Protocol Amendments, Continuing Review Reports, Protocol Violations and Deviations, and Serious Adverse Event Reports as necessary
* Reports adverse events, serious adverse events, and unanticipated device adverse events in accordance with the protocol and the Partners Human Research Committee policies.
* Attends sponsor held coordinator meetings, making presentations regarding study status as needed.
* Attends sponsor and professional training; prepares and may present information gained at division staff meetings. Attends annual continuing education training related to clinical research and vascular surgery.
* Participates on or leads division or department committees regarding clinical research, process management and skills development.
* Serves as a lead member of the clinical trials staff, working with management to coordinate activities that support the team and its development.
* Participates in applicant interviews and makes recommendations to management.
* Coordinates and leads the onboarding of new clinical trial staff in collaboration with management. Participates in the creation and revision of the staff orientation program. Ensures orientation is complete and initial learning and competency attained. Provides feedback to management.
* Develops and provides periodic training to research staff regarding research policies, practices, and regulations, including protocol implementation and compliance practices.
* Provides functional oversight and guidance to and acts as a resource for other team members regarding questions, studies, regulations, etc.
* Troubleshoots study process issues for self and team members, resolving complex concerns and collaborating with management and industry/study liaisons where necessary.
* May conduct staff meetings in the absence of management personnel.
* Participates in projects and other responsibilities as needed.
Skills/Abilities/Competencies Required:
* Advanced understanding of clinical trial study design and protocols, data management and reporting
* Advanced working knowledge in Good Clinical Practice, FDA Code of Federal Regulations, and ICH guidelines
* Able to understand, interpret, communicate and train others on study protocols and data
* Ability to follow complex protocols, keep excellent written records and adhere to timelines
* Understanding of clinical trials budget preparation and management
* Strong data management and analytical skills; some understanding or ability in statistical analysis helpful
* Obtains and maintains Partners Healthcare required GCP and CITI certifications
* Computer skills necessary (MS Word, Excel, PowerPoint and Outlook).
* Ability to effectively engage with and influence others; able to build working relationships; can work independently and as a team member, leading others when needed
* Strong written and verbal communication skills to support diverse constituents, including patients, physicians, sponsors, and staff from other departments throughout the hospital and affiliates
* Able to prepare materials for presentation and publication if needed
* Able to facilitate cooperation and teamwork both within the institution and with the corporate sponsor companies; effective skills in problem resolution
* Effective meeting management and presentation skills
* Adept at orienting and training new or temporary research staff
* Act as study resource for subject and family as well as colleagues
* Demonstrate respect and professionalism for subjects' rights, HIPAA guidelines, and individual needs of research subjects
* Is knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).
* Proficient with on-line medical literature database systems
* Ability to prepare and monitor research budgets
Education:
BA/BS required in related field of study.
Experience:
A minimum of 5 years of clinical research experience is required. Experience with multi-center study protocols required. Physician initiated (IDE or IND) trial experience preferred. Some direct experience working with the FDA on clinical trial audits is preferred.
Working Conditions:
* Normal office conditions. Fully onsite (no remote option).
* May be required to work in clinical conditions (including the operating room). May be exposed to minimal radiation.
* May be required to attend meetings outside of regularly scheduled hours and locations, including domestic travel
* On call schedule (dependent on enrolling trials) may be required.
Additional Job Details (if applicable)
Remote Type
Onsite
Work Location
60 Blossom Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement:
The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Research Study Coordinator, Infectious Diseases
Clinical Research Coordinator Job 6 miles from Revere
Research Study Coordinator, infectious Diseases
Schedule: 40 hours per week, Hybrid (4 days on-site/1 day remote per week)
ABOUT BMC:
At Boston Medical Center (BMC), our diverse staff works together for one goal - to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience.
You'll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you'll have the tools you need to take charge of your own practice environment.
POSITION SUMMARY:
The Study Coordinator is responsible for on- and off-site study implementation and data management of clinical research studies on tuberculosis (TB) at both domestic (Boston) and international (South Africa) sites. The Study Coordinator will be responsible for development and oversight of study documentation and maintaining ethics compliance.
Interested candidates should have strong data analysis and computing programming skills and be able to manipulate, transform, analyze and summarize large data sets.
The Study Coordinator will work directly with study field teams to meet project milestones and support investigators in dissemination of findings.
JOB RESPONSIBILITIES:
Protocol and study document development
Supports development of clinical/scientific study protocols, informed consent forms (ICFs), manuals of procedure (MOPs), and standard operating procedures (SOPs) for domestic and international studies.
Supports development of data management plans (DMPs) and clinical quality management plans (CQMPs) for studies, including plans for regular quality control/assurance (QA/QC) on study data and protocol implementation.
Performs quality assurance/control (QA/QC) per DMPs and CQMPs for each protocol. Coordinate QA/QC with on-site staff and investigators.
Develops training materials on study protocols, research and clinical SOPs, and data collection procedures and supports training of study teams [e.g., research assistants (RAs), research nurses, field workers].
Data Management and Analysis
Data manipulation, including cleaning, transformation, and summary
Develops case report forms (CRFs) and other data collection tools and leads design and validation of electronic data capture (EDC) systems and databases (e.g., REDCap).
Development, execution and management of QA/QC plans and R code.
Maintains EDCs and data dictionaries. Ensures data integrity and protocol adherence by conducting routine on-site and remote QA/QC procedures per DMPs and CQMPs.
Works with investigators and statisticians in creating databases/datasets for analyses and performs descriptive analyses using statistical package (e.g., R).
Study Implementation
Maintains ethics and regulatory compliance, including initial international and domestic institutional review board (IRB) and ethics committee (ECs) submissions, amendments, reportable events, and annual reporting. Maintains regulatory binders and study master files.
Oversees the launch of new domestic and international studies. Ensures protocol adherence and smooth study implementation for ongoing studies. Serves as the conduit between various study sites, including laboratory partners.
Conducts domestic and international site monitoring visits to meet with stakeholders and perform audits on study protocol adherence and implementation.
Reports to investigators on study progress and protocol milestones. Generates routine progress reports and aids in preparing annual reports to donors and ethics.
Works closely with Manager to navigate deviations from protocol, displays forethought in identifying potential crises and devises appropriate contingency plans
Other duties
Aids in preparation of abstracts, posters, and manuscripts for scientific meetings and journals.
Schedules and leads regular study team meetings, sets agendas, and records minutes for distribution. Prioritizes work to ensure appropriate and timely preparation for meetings and meets deliverable deadlines.
Performs other duties as needed or as assigned to ensure smooth operations and responsiveness of projects and team.
Spends ~5-10% time at international study sites (e.g., Western Cape, South Africa)
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).
JOB REQUIREMENTS
EDUCATION:
Bachelors' degree required, preferably in Public Health.
MS/MPH strongly preferred
EXPERIENCE:
Must have minimum of two (2) years experience with R statistical computing software, understanding of data management in clinical research and experience with clinical/epidemiologic research, especially in international health/infectious diseases.
KNOWLEDGE AND SKILLS:
Understanding of clinical research components - data collection issues, human subject's protection, quality assurance and control.
Familiarity with ICH Good Clinical Practices (GCP) consistent with registration clinical trials (FDA Guidance for Industry for Computerized Systems used in Clinical Trials (Title 21 CFR Part 11) preferred.
Excellent programming ability in R statistical computing software is required. Excellent proficiency with Microsoft Office applications is required.
Adept at communicating questions and proactively communicating concerns
Working knowledge of electronic data capture systems, specifically, REDCap.
Demonstrated progressive work experience in project management and project planning.
Excellent oral and written communication skills and interpersonal skills
This position is grant funded through 5/31/26. There may be opportunity beyond this grant funding for position integration into ongoing operations.
JOB BENEFITS:
Competitive pay
Tuition reimbursement and tuition remission programs
Highly subsidized medical, dental, and vision insurance options
Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.
ABOUT THE DEPARTMENT:
As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn't dictate health.
Boston Medical Center is an Equal Opportunity/Affirmative Action Employer. If you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail to ************************* or call ************ to let us know the nature of your request.
Equal Opportunity Employer/Disabled/Veterans
Coordinator of ELA and Social Studies Grades 6-8 SY 2025-2026
Clinical Research Coordinator Job 23 miles from Revere
TO: All Teaching and Administrative Personnel Brockton Public Schools FROM: Dr. Kathleen F. Moran, Assistant Superintendent of Human Resources SUBJECT: Coordinator of ELA and Social Studies Grades 6-8- School Year 2025-2026 The above captioned position is brought to the attention of all teaching and administrative personnel.
Qualifications:
Supervisor/Director license in appropriate content area.
Five or more years successful teaching (ELA/Social Studies) and/or administrative experience.
Strong organizational and excellent oral and written communication skills.
Familiar with MA curriculum Frameworks and district curriculum initiatives and programs.
Ability and experience working with educators to model best practices in ELA or Social Studies.
Experience providing and coordinating professional development activities for teachers in the areas of ELA or Social Studies.
Demonstrated skill in organization, leadership, communication, problem solving, collaboration, and team building.
Responsibilities
Work with professional staff and schools to improve ELA and Social Studies instruction.
Coordinate district wide curriculum initiatives in ELA and Social Studies.
Serve as a district liaison to DESE in the areas of ELA and Social Studies.
Conduct model lessons for classroom teachers and specialists.
Mentor teachers in best practices in ELA and Social Studies.
Provide professional development in ELA and Social Studies for professional staff.
Determine and recommend materials for budget to enhance initiatives in ELA and Social Studies.
Recommend current resources and best practices in ELA and Social Studies.
Work with other systemwide curriculum coordinators in implementing district wide curriculum initiatives.
Perform other related duties as assigned by the Assistant Superintendent of Learning and Teaching Grades 6-12 and Alternative
Schools.
Compensation: 1.30 ratio for an eleven-month work year
Reports to: Assistant Superintendent of Learning and Teaching Grades 6-12 and Alternative Schools
A resume of the applicant's educational and professional background with specific emphasis should accompany the letter of application. A copy of administrative certification should also be submitted.
Coordinator of ELA and Social Studies Grades 6-8 SY 2025-2026
Clinical Research Coordinator Job 23 miles from Revere
TO: All Teaching and Administrative Personnel Brockton Public Schools FROM: Dr. Kathleen F. Moran, Assistant Superintendent of Human Resources SUBJECT: Coordinator of ELA and Social Studies Grades 6-8- School Year 2025-2026 The above captioned position is brought to the attention of all teaching and administrative personnel.
Qualifications:
Supervisor/Director license in appropriate content area.
Five or more years successful teaching (ELA/Social Studies) and/or administrative experience.
Strong organizational and excellent oral and written communication skills.
Familiar with MA curriculum Frameworks and district curriculum initiatives and programs.
Ability and experience working with educators to model best practices in ELA or Social Studies.
Experience providing and coordinating professional development activities for teachers in the areas of ELA or Social Studies.
Demonstrated skill in organization, leadership, communication, problem solving, collaboration, and team building.
Responsibilities
Work with professional staff and schools to improve ELA and Social Studies instruction.
Coordinate district wide curriculum initiatives in ELA and Social Studies.
Serve as a district liaison to DESE in the areas of ELA and Social Studies.
Conduct model lessons for classroom teachers and specialists.
Mentor teachers in best practices in ELA and Social Studies.
Provide professional development in ELA and Social Studies for professional staff.
Determine and recommend materials for budget to enhance initiatives in ELA and Social Studies.
Recommend current resources and best practices in ELA and Social Studies.
Work with other systemwide curriculum coordinators in implementing district wide curriculum initiatives.
Perform other related duties as assigned by the Assistant Superintendent of Learning and Teaching Grades 6-12 and Alternative
Schools.
Compensation: 1.30 ratio for an eleven-month work year
Reports to: Assistant Superintendent of Learning and Teaching Grades 6-12 and Alternative Schools
A resume of the applicant's educational and professional background with specific emphasis should accompany the letter of application. A copy of administrative certification should also be submitted.
Clinic Coordinator - (Mon-Fri 10am-6:30pm)
Clinical Research Coordinator Job 6 miles from Revere
Clinic Coordinator
Location: 450 Brookline Ave, Boston, MA 02215 Category: Administration Support/Customer Service Employment Type: full time
Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer.
Responsibilities:
Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process.
Manage complex scheduling to meet patient needs.
Act as a liaison for patients, families and providers.
Respond to emergent and compliance matters with creative problem solving and critical thinking.
Qualifications
Bachelor's degree preferred.
0 - 1 year experience in a customer service setting.
Proficiency in technology and complex computer systems required.
Ability to work in a fast paced and complex clinical environment.
Professional Growth:
The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry.
Well-Being and Benefits
Health, Dental and Vision Insurance
Time Off
Family & Child Care Benefits and Resources
Retirement Programs
Life Insurance
Short Term Disability
Health Savings Account
Flexible Spending Account
Transportation
LGBTQ+
Our Benefits Partners Include:
Harvard Pilgram Health Care
Delta Dental
Eye Med
Fidelity Investments
Sentinel Benefits Group
Prudential
Voya Financial
TIAA
Care.com
Edukate
Headspace
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Join Our Talent Network
Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.
Clinical Coordinator (Registered Nurse) - Cardiovascular OR
Clinical Research Coordinator Job 6 miles from Revere
The Clinical Coordinator will:
Plan, organize, and oversee, daily clinical and administrative operations of designated unit/program/service
Prepare staff schedules, request and allocate resources, and facilitate coordination of care/services to meet patient care and operations requirements
Develop, recommend, and implement internal standards, policies and procedures to improve quality and cost-effectiveness of patient care
Select, supervise, and evaluate nursing and clinical support personnel and develops and provides staff education/development programs
Lead and participate in hospital, departmental and multidisciplinary programs, committees and special projects.
Collaborate seamlessly across disciplines, working closely with each member of the team.
To qualify, you must have:
A Bachelor of Science in Nursing and 7+ years of RN experience strongly preferred. (Staff Nurse II or Staff Nurse III level strongly preferred)
Minimum 4 years of pediatric Cardiac OR experience.
A Master's Degree in Nursing preferred.
A Bachelor's Degree in Nursing
Analytical skills to resolve highly complex problems requiring the application of clinical, scientific or technical principles, theories and concepts and in-depth, cross-functional, experience-based knowledge.
Effective communication collaboration and computer skills
Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
#LI-Onsite