Regulatory Affairs Coordinator

A company is looking for a Regulatory Affairs Coordinator I who will ensure regulatory requirements for clinical trials are met.

Key Responsibilities

Maintain and organize study-specific regulatory binders

Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB

Manage adverse event documentation and report to the sponsor and IRB as required

Required Qualifications

Bachelor's Degree in a related field of study required

Experience may be accepted in lieu of a degree

Working knowledge of clinical research protocols

Computer literacy

Good organizational skills