Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work.

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai.

The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC! This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, participating in weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB)!

• 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 comply with regulatory requirements and institutional policies.
• 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
• Participate in 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.
• Coordinate strategies to improve existing standard operating procedures related to regulatory affairs
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
• Maintains research practices using Good Clinical Practice (GCP) guidelines
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law
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• Working Title: Regulatory Coordinator II - Study Activation (Remote Option)
• Department: SOCCI Clinical Research Office
• Business Entity: Academic / Research
• City: Los Angeles
• Job Category: Compliance/Quality
• Job Specialty: Research Compliance
• Position Type: Full-time
• Shift Length: 8 hour shift
• Shift Type: Day