Hybrid Regulatory Affairs Coordinator for Clinical Trials

2200 The Brigham and Women's Hospital, Inc.; 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 clinical teams, and receive training on institutional and federal regulations governing research.

Responsibilities include preparing submissions, maintaining regulatory binders, and tracking deadlines, with hybrid work location in Boston and surrounding areas.

Qualifications

• Education: Bachelor's Degree in Related Field required; experience in lieu of degree may be considered.
• 0-1 years of experience in regulatory affairs or clinical research environment.

Responsibilities

• Prepare and submit protocol amendments and continuing reviews to the IRB.
• Revise informed consent documents with new risk information.
• Maintain regulatory documentation per institutional, sponsor, and federal requirements.

Skills

Attention to detail

Organizational skills

Follow directions

Computer literacy

Clinical research protocols

Education

Bachelor's degree in 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 clinical teams, and receive training on institutional and federal regulations governing research.

Responsibilities include preparing submissions, maintaining regulatory binders, and tracking deadlines, with hybrid work location in Boston and surrounding areas.