What are the responsibilities and job description for the Regulatory Coordinator position at Irvine Clinical Research?
The Irvine Clinical Research site network is the largest of its kind on the West Coast. With 5 research centers in California, we are leaders in the search for new treatments in neurology, psychiatry, and obesity medicine. Our largest area of research is in Alzheimer’s Disease prevention and treatment drug trials, and our doctors were the largest contributors in the world to the most recently FDA-approved medication in Alzheimer’s Disease.
The Regulatory Coordinator is responsible for managing and maintaining clinical study regulatory documentation in full compliance with IRB, sponsor, and FDA requirements, ensuring all records remain inspection-ready at all times. This role supports study startup, maintenance, and close-out activities while serving as a key liaison between investigators, sponsors, and IRBs.
\n- Maintain regulatory files at inspection-ready status at all times on paper and/or electronic platforms across multiple sites
- Report protocol deviations and safety events to IRB per regulations and sponsor requirements
- Receive, track, and distribute Safety Reports
- Work closely with Study Coordinators on new study startup, protocol amendments, and updated informed consent forms
- Prepare regulatory documents for new study submission to IRB and Sponsor in a timely and accurate manner
- Liaise with Sponsor and IRB contacts on a regular basis
- Manage study close-out activities
- Serve as a primary point of contact for monitoring visits, in-person or remote
- Verify and maintain various training logs for site study staff
- Maintain Delegation of Authority, FDA 1572, DEA 222, and other compliance documents
- Maintain staff CVs accurately and precisely, semi-annually
- Oversee annual equipment calibration
- Archive closed studies; if applicable, prepare shipment to off-site storage
- Provide clerical and administrative support
- One or more years of clinical research regulatory experience
- Excellent communication and social skills in spoken and written English
- Attention to detail and the ability to handle multiple tasks with precision
Salary : $66,500 - $80,000