Regulatory Affairs Coordinator

Job Summary

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