Clinical Research Associate - Regulatory & IRB (Hybrid)

Partner's Healthcare; Boston (MA); Hybrid; USD 28,000 - 40,000; Full time

Job summary

Mass General Brigham is seeking a Clinical Research Regulatory Coordinator I to ensure regulatory compliance for clinical trials. The role works with clinical teams, IRB, sponsors, and federal agencies to maintain proper documentation and oversight at the site.

The position requires a Bachelor's degree in a related field and 1–2 years of research experience. Remote/hybrid work is available at the 55 Fruit Street location in Boston, MA.

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, and communication

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 updated protocol requirements.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the 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

Regulatory compliance knowledge

Clinical research protocols

Communication skills

Interpersonal skills

Education

Bachelor's Degree in a Related Field

Job description

Mass General Brigham is seeking a Clinical Research Regulatory Coordinator I to ensure regulatory compliance for clinical trials. The role works with clinical teams, IRB, sponsors, and federal agencies to maintain proper documentation and oversight at the site.

The position requires a Bachelor's degree in a related field and 1–2 years of research experience. Remote/hybrid work is available at the 55 Fruit Street location in Boston, MA.