Cedars-Sinai is a nonprofit academic healthcare organization serving the diverse Los Angeles community and beyond. We are one of the leading institutes for competitive research funding from the National Institutes of Health. As an international leader in biomedical research, we translate discoveries into successful treatments with global impact. Cedars-Sinai is a hub for biomedical research with discoveries occurring in 26 departments and institutes that encompass the full spectrum of medicine.

Beyond an outstanding benefit package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.

The Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. 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 Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or 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).

• Provides supervision of other regulatory staff.
• Ability to identify areas of project interest and connect with appropriate support group: SPIN, IRB, Tech Transfer
• Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
• 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.
• Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• May participate in internal auditing of regulatory documents.
• May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.
• May participate in centralized activities of the department or institution.
• May plan and 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.
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with organizational policies and procedures.
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• Working Title: Regulatory Coordinator III - Cancer Institute
• Department: Cancer Institute
• Business Entity: Academic / Research
• City: West Hollywood
• Job Category: Compliance/Quality
• Job Specialty: Research Compliance
• Position Type: Full-time
• Shift Length: 8 hour shift
• Shift Type: Day