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Regulatory Coordinator – CTSI
Work Location
Los Angeles,CA
Job #23556
Work Hours
Monday-Friday; 8:00am-5:00pm
Employment Type
2 – Staff- Career
Duration
Indefinite
Salary Range
$30.56-60.82 Hourly
Posted Date
March 27, 2025
Bargaining Unit
99
Apply as Internal/Current Employee
Find the cures you know are out there. At UCLA Health, you make it happen as part of a groundbreaking Research team, working to understand hundreds of medical disorders and improving processes for dozens of procedures across the globe.
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JOB DUTIES
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JOB QUALIFICATIONS
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:
- 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
DR. ISLA GARRAWAY
UCLA has incredible resources and a team science approach. The ability to work with collaborative teams and access the amazing resources around campus is the best part about being at UCLA.
RADU
UCLA is very diverse in its personnel as well as its many research fields studied