Regulatory Affairs Coordinator

Clinical Research Regulatory Coordinator I (CRRCI)

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Mass General Brigham

Mass General Brigham relies on a wide range of professionals to advance our mission. The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), sponsors, and federal regulatory agencies. The CRRCI will be trained on institutional and federal regulations governing clinical research.

This role does not involve patient contact.

• Maintain and organize study‑specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents to include new risk information and/or updated protocol requirements.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients; report to sponsor and IRB as required.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to various regulatory entities.
• Participate in monitoring visits and file all monitoring visit correspondence.
• Ensure appropriate documentation of delegation and training for all study staff members.
• Maintain screening and enrollment logs.

• Bachelor’s degree in a related field.
• Experience in clinical research protocols acceptable in lieu of a degree.
• Careful attention to detail.
• Good organizational skills.
• Ability to follow directions.
• Good communication skills.
• Computer literacy.
• Working knowledge of clinical research protocols.

Standing 3‑33% of the time, walking 3‑33%, sitting 67‑100%, lifting 3‑33% (20‑35 lbs), carrying 3‑33% (20‑35 lbs), pushing/pulling/climbing/balancing rarely, stooping occasionally, kneeling/crouching/crawling rarely, reaching 3‑33%, gross manipulation continuously 67‑100%, fine manipulation frequently 34‑66%, feeling 67‑100%, vision far/near continuously, talking/hearing continuously. Remote work location: 101 Merrimac Street.

Competitive base pay $20.16 – $29.01 per hour, with comprehensive benefits and opportunities for career advancement.

Mass General Brigham Incorporated is an Equal Opportunity Employer. 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 other status protected under law. Reasonable accommodations will be provided as needed.