Hybrid Regulatory Affairs Coordinator – Clinical Trials

Brigham and Women's Hospital, Inc.; Boston (MA); Hybrid; USD 28,000 - 40,000; Full time

Job summary

Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs Coordinator I to support regulatory submissions for clinical trials. The role involves collaboration with IRBs, sponsors, and study teams to ensure compliance and accurate documentation.

Qualification includes a Bachelor's degree and 0–1 year of experience, with a hybrid work arrangement at 20 Shattuck Street, Boston. You will manage regulatory binders, training records, and deadlines to support safe, compliant research

Qualifications

• Bachelor's degree required.
• 0–1 year of experience preferred.
• IRB familiarity beneficial.
• Clinical trial knowledge advantageous.

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.
• Maintain regulatory documentation for assigned studies per requirements.
• Manage adverse events and deviation/violation/exception documentation for enrolled patients.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors.
• Collect, complete, and submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and file monitoring correspondence.
• Track deadlines and milestones for regulatory submissions.
• Collaborate with study teams to gather information for regulatory submissions.
• Maintain personnel documentation (training, licenses, etc.).
• Assist with regulatory study information in systems and regulatory tracking tools.
• Prepare and maintain regulatory binders and ensure readiness for review.
• Assist with personnel additions/removals and update systems accordingly.
• Support submissions of deviations and safety reports under supervision.
• Communicate upcoming deadlines and outstanding documentation.
• Maintain regulatory tracking spreadsheets and databases.
• Assist with close-out activities and record maintenance.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research protocols

Education

Bachelor's Degree in related field

Job description

Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs Coordinator I to support regulatory submissions for clinical trials. The role involves collaboration with IRBs, sponsors, and study teams to ensure compliance and accurate documentation.

Qualification includes a Bachelor's degree and 0–1 year of experience, with a hybrid work arrangement at 20 Shattuck Street, Boston. You will manage regulatory binders, training records, and deadlines to support safe, compliant research