Hybrid Regulatory Clinical Research Associate

Massachusetts General Hospital; Boston (MA); Hybrid; USD 57,767,000 - 83,164,000; Full time

Job summary

Mass General Brigham in Boston seeks a CRRCI regulatory specialist to ensure compliance with institutional and federal requirements for clinical trials. You will work with clinical teams, IRB, sponsors, and regulators to support study conduct.

The role requires attention to detail, knowledge of clinical research protocols, and strong communication with vendors and investigators. Hybrid work at 55 Fruit Street offers collaboration with a diverse team and opportunities to advance patient-focused

Qualifications

• Education: Bachelor's Degree in a Related Field of Study required.
• Experience: Research-Related Experience 1-2 years preferred.
• Knowledge, Skills and Abilities: Attention to detail, compliance awareness, communication with patients, vendors, CROs, and staff.

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 to include new risk information and protocol updates.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to sponsor and IRB as required.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to various regulatory entities.
• Participate in monitoring visits and maintain a record of all correspondence related to these visits.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Effective communication

Interpersonal skills

Education

Bachelor's Degree in Related Field

Job description

Mass General Brigham in Boston seeks a CRRCI regulatory specialist to ensure compliance with institutional and federal requirements for clinical trials. You will work with clinical teams, IRB, sponsors, and regulators to support study conduct.

The role requires attention to detail, knowledge of clinical research protocols, and strong communication with vendors and investigators. Hybrid work at 55 Fruit Street offers collaboration with a diverse team and opportunities to advance patient-focused