New 
Regulatory Affairs Coordinator I
 Mass General Brigham (Enterprise Services) | |
 United States, Massachusetts, Boston | |
| 101 Merrimac Street (Show on map) | |
 Feb 20, 2026 | |
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Summary
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. Will be trained on the institutional and federal regulations governing clinical research. Does this position require Patient Care? No Essential Functions -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. -Maintain and organize study-specific regulatory binders. -Manage adverse events 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. Education Physical Requirements
Mass General Brigham Incorporated is an Equal Opportunity 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. | |