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- Regulatory Project Coordinator
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Regulatory Coordinator Iii (Remote)
Company | Cedars-Sinai |
Address | Los Angeles, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | IT Services and IT Consulting,Research Services,Hospitals and Health Care |
Expires | 2023-08-03 |
Posted at | 10 months ago |
Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work. Those that reside outside of these states will not be considered
- Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
- May participate in internal auditing of regulatory documents.
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
- Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
- Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
- Provides supervision of other regulatory staff.
- May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.
- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
- Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
- May participate in centralized activities of the department or institution.
- Bachelor's Degree
- Five (5) years minimum of directly related experience.
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