Regulatory Coordinator I - Neurosciences - Hybrid
Cedars-Sinai · Los Angeles
Job Description
Are you ready to bring your skills to a world-class healthcare organization recognized as one of the top ten in the United States? Come join our team!
About the Role
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
This position will provide support to the Departments of Neurology and Neurosurgery at Cedars-Sinai Medical Center.
The Regulatory Coordinator I prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Research Department when meeting with sponsors, attending team meetings, and working with other staff to ensure all regulatory documents and requirements are up-to-date. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
- Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
- 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 follow regulatory requirements and institutional policies.
- Works closely with the clinical trial coordinator, research staff, and investigators to make sure that all regulatory documents for the research studies are up-to-date.
- Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Qualifications
Education, Experience, and Skills:
- Bachelor's degree, required.
- One (1) year minimum of directly related experience is required.
- Specialty research certification, preferred.
Education, Experience, and Skills:
- Bachelor's degree, required.
- One (1) year minimum of directly related experience is required.
- Specialty research certification, preferred.
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