Clinical Trials Regulatory Affairs Coordinator

Mass General Brigham; Boston (MA); Hybrid; USD 42,000 - 60,000; Full time

Job summary

Mass General Brigham is seeking a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. You will work with IRB, sponsors, and trial teams to prepare submissions and maintain regulatory documentation.

The role involves monitoring deadlines, updating informed consent, and assisting with regulatory binders. Remote type is hybrid; location is 20 Shattuck Street, with a 40-hour work week and day shift in the United States.

Qualifications

• Attention to detail and accuracy are essential.
• Strong organizational and time-management abilities.
• Ability to follow directions and processes precisely.
• Computer literacy and familiarity with basic software tools.
• Knowledge of clinical research protocols and regulations.

Responsibilities

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risks or protocol updates.
• Maintain regulatory documentation in line with requirements and GCP guidance.
• Manage adverse events and deviations, reporting to sponsor and IRB.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of IRB communications and study staff.
• Collect regulatory documents for submission to authorities.
• Participate in monitoring visits and correspond with study teams.
• Track deadlines and milestones for regulatory submissions.
• Collaborate with CR coordinators and investigators for filings.
• Keep personnel documentation (training, licenses, logs) current.
• Assist with study information in institutional systems and trackers.
• Prepare regulatory binders and ensure documents are complete and signed.
• Assist with personnel changes and related regulatory updates.
• Support documentation for protocol deviations and close-out activities.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research knowledge

Education

Bachelor’s Degree or related field

Job description

Mass General Brigham is seeking a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. You will work with IRB, sponsors, and trial teams to prepare submissions and maintain regulatory documentation.

The role involves monitoring deadlines, updating informed consent, and assisting with regulatory binders. Remote type is hybrid; location is 20 Shattuck Street, with a 40-hour work week and day shift in the United States.