Clinical Trials Regulatory Associate

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

Job summary

The Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs professional to ensure compliance with clinical trial regulations under general supervision. You will work with IRBs, sponsors, and federal agencies, gaining training on institutional and federal requirements governing clinical research.

Onsite position with regular day shift, located at 77 Avenue Louis Pasteur. The role includes preparing amendments, safety reports, and maintaining regulatory documentation throughout the

Qualifications

• Bachelor's Degree in related field required
• Research related experience 1-2 years preferred
• Attention to detail and accuracy in regulatory work
• Working knowledge of clinical research protocols
• Ability to communicate effectively with patients, vendors, CROs and staff
• Strong interpersonal and communication skills

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk info and updated protocol requirements.
• Manage adverse event and deviation/violation/exception documentation; report to sponsor/IRB.
• Maintain source documentation of correspondence with IRB, investigators, and sponsors.
• Submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and document correspondence.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Interpersonal skills

Education

Bachelor's Degree related field

Job description

The Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs professional to ensure compliance with clinical trial regulations under general supervision. You will work with IRBs, sponsors, and federal agencies, gaining training on institutional and federal requirements governing clinical research.

Onsite position with regular day shift, located at 77 Avenue Louis Pasteur. The role includes preparing amendments, safety reports, and maintaining regulatory documentation throughout the