Regulatory Coordinator - CTSI
Apply NowCompany: UCLA Health
Location: Los Angeles, CA 90011
Description:
Description
The Regulatory Coordinator is responsible for regulatory coordination of clinical research studies within assigned units, departments or divisions. You will perform detailed review of clinical research protocols and utilize that information to prepare, manage, and submit all required study/regulatory documents and all required applications and forms related to internal UCLA requirements, FDA requirements, sponsor requirements, etc. You will work with study monitors to process, review and collect the appropriate regulatory documents in a timely manner and in compliance with federal, state, and university mandated laws, regulations and policies.
Other duties include:
Salary Range: $30.56 - $60.82/Hourly
The Regulatory Coordinator is responsible for regulatory coordination of clinical research studies within assigned units, departments or divisions. You will perform detailed review of clinical research protocols and utilize that information to prepare, manage, and submit all required study/regulatory documents and all required applications and forms related to internal UCLA requirements, FDA requirements, sponsor requirements, etc. You will work with study monitors to process, review and collect the appropriate regulatory documents in a timely manner and in compliance with federal, state, and university mandated laws, regulations and policies.
Other duties include:
- Utilizing research compliance concepts and apply organizational policies and procedures to perform detailed review of clinical research protocols and develop and implements activation project plan.
- Reviewing protocol amendments or changes in order to determine if budget and/or contract amendments must be implemented. Notify Principal Investigator, Central Administration, team leader and study team of protocol changes and revision requirements. Act as liaison between all other required hospital and clinic departments in order to reassess protocol requirement changes and prices.
- Managing all document updates and uploads in the Clinical Research Management System (CRMS) including updated consents, and that research staff are aware of the need to re-consent patients if the informed consent has been amended.
- Overseeing and managing study closeout visits, and ensure proper submission and maintenance of all required regulatory documentation for study closure, in accordance with applicable laws and institutional policies.
Salary Range: $30.56 - $60.82/Hourly