Hybrid Regulatory Affairs Coordinator, Clinical Trials

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

Benefits offered by this job

Hybrid work arrangement

Job summary

Mass General Brigham seeks a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. The role collaborates with IRB, sponsors, and clinical teams, with training on federal and institutional regulations governing research.

The position does not involve direct patient care. The role supports submissions, maintains documentation, tracks deadlines, and assists with study close-out activities under supervision.

Qualifications

• Education/Bachelor's degree required in a related field.
• 0-1 yrs of experience acceptable.
• Good attention to detail and organizational skills.

Responsibilities

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk information or updated protocol requirements.
• Maintain regulatory documentation per requirements and GCP guidelines.
• Manage adverse events and deviation/violation/exception documentation for enrolled patients.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research protocols

Education

Bachelor's Degree Related Field of Study

Job description

Mass General Brigham seeks a Regulatory Affairs Coordinator I to ensure regulatory compliance for clinical trials. The role collaborates with IRB, sponsors, and clinical teams, with training on federal and institutional regulations governing research.

The position does not involve direct patient care. The role supports submissions, maintains documentation, tracks deadlines, and assists with study close-out activities under supervision.