Regulatory Affairs Coordinator I

Mass General Brigham•Boston, MA

1d•Hybrid

About The Position

Mass General Brigham is a not-for-profit organization dedicated to patient care, research, teaching, and community service, relying on a diverse range of professionals to achieve its mission. The organization strives to provide exceptional care and believes in the power of high-performing teams to drive groundbreaking medical discoveries. The Regulatory Affairs Coordinator I works under general supervision to ensure that all regulatory requirements for clinical trials are met. This position involves close collaboration with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The individual hired for this role will receive comprehensive training on the institutional and federal regulations that govern clinical research. This position does not involve direct patient care.

Requirements

Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes
Careful attention to detail.
Good organizational skills.
Ability to follow directions.
Computer literacy.
Working knowledge of clinical research protocols.

Responsibilities

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.