Hybrid Regulatory Affairs Coordinator Clinical Trials

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

Job summary

The Brigham and Women's Hospital, Inc. seeks a Regulatory Affairs Coordinator I to ensure regulatory requirements for clinical trials are met under general supervision. You will collaborate with IRBs, sponsors, and federal agencies.

Main duties include preparing submissions, updating informed consent, maintaining regulatory documents, tracking deadlines, and supporting monitoring visits. This is a hybrid, 40-hour work week role.

Qualifications

• Bachelor's Degree or related field required.
• Can this role accept experience in lieu of a degree? Yes.

Responsibilities

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk information and/or updated protocol requirements.
• Maintain regulatory documentation for assigned studies per institutional, sponsor, and regulatory requirements.
• Manage adverse events and deviations and report to sponsor/IRB as required.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of IRB communications and study team correspondence.
• Collect, complete, and submit regulatory documents to regulatory entities.
• Participate in monitoring visits and file monitoring correspondence.
• Track regulatory deadlines and study milestones.

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. seeks a Regulatory Affairs Coordinator I to ensure regulatory requirements for clinical trials are met under general supervision. You will collaborate with IRBs, sponsors, and federal agencies.

Main duties include preparing submissions, updating informed consent, maintaining regulatory documents, tracking deadlines, and supporting monitoring visits. This is a hybrid, 40-hour work week role.