Clinical Trials Regulatory Associate

The General Hospital Corporation; Boston (MA); On-site; USD 28,000 - 40,000; Full time

Job summary

The Brigham and Women's Hospital, Inc. is seeking a regulatory professional to ensure clinical trial regulatory requirements are met under supervision.

You will work with clinical teams, IRBs, sponsors, and federal agencies, receiving training on governing regulations. Responsibilities include maintaining study binders, submitting protocol amendments and safety reports, updating consent documents, and reporting adverse events.

Qualifications

• Bachelor's Degree in a related field required; experience in lieu of degree acceptable.
• 1-2 years research-related experience preferred.
• Attention to detail and knowledge of clinical research protocols.

Responsibilities

• Maintain and organize study regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to IRB.
• Revise informed consent documents with updated risk information or protocol requirements.
• Manage adverse event and deviation documentation and report to sponsor/IRB.
• 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 maintain records of visits.

Skills

Attention to detail

Regulatory knowledge

Clinical research

Communication

Education

Bachelor's Degree Related Field

Job description

The Brigham and Women's Hospital, Inc. is seeking a regulatory professional to ensure clinical trial regulatory requirements are met under supervision.

You will work with clinical teams, IRBs, sponsors, and federal agencies, receiving training on governing regulations. Responsibilities include maintaining study binders, submitting protocol amendments and safety reports, updating consent documents, and reporting adverse events.