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