Clinical Research Regulatory Coordinator I
About The Position
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.
Requirements
- Careful attention to detail
- Good organizational skills
- Ability to follow directions
- Good communication skills
- Computer literacy
- Working knowledge of clinical research protocols
- Education: Bachelor's Degree Related Field of Study required
Responsibilities
- 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 through the course of the study
- Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Hospitals
Number of Employees
5,001-10,000 employees
