Hybrid Regulatory Affairs Coordinator — Clinical Trials

Partner's Healthcare; Boston (MA); Hybrid; USD 28,000 - 40,000; Full time

Job summary

The Brigham and Women's Hospital, Inc. is part of Mass General Brigham and seeks a Regulatory Affairs Coordinator I to support regulatory submissions for clinical trials. The role involves collaboration with IRB, sponsors, and clinical teams to ensure compliance with institutional and federal regulations.

The position offers a hybrid work arrangement in Boston, MA, with responsibilities including amendments, safety reporting, and regulatory documentation management consistent with GCP guidelines.

Qualifications

• Bachelor's Degree in a related field required.
• 0–1 year of experience acceptable.

Responsibilities

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk information or updated protocol requirements.
• Maintain regulatory documentation for assigned studies per institutional, sponsor, and regulatory requirements.
• Manage adverse events and deviation/violation/exception documentation for all enrolled patients.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of correspondence with IRB, investigators, and sponsors.
• Collect, complete, and submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and file monitoring visit correspondence.
• Track regulatory deadlines and study milestones (continuing reviews, amendments, personnel changes, training expirations).
• Work with study teams to collect information for regulatory submissions.
• Maintain current study personnel documentation (CITI/GCP training, CVs, licenses, COI logs).
• Assist with regulatory tracking tools and systems.
• Prepare and maintain regulatory binders and ensure documents are signed and dated.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research knowledge

Education

Bachelor's degree in related field

Job description

The Brigham and Women's Hospital, Inc. is part of Mass General Brigham and seeks a Regulatory Affairs Coordinator I to support regulatory submissions for clinical trials. The role involves collaboration with IRB, sponsors, and clinical teams to ensure compliance with institutional and federal regulations.

The position offers a hybrid work arrangement in Boston, MA, with responsibilities including amendments, safety reporting, and regulatory documentation management consistent with GCP guidelines.