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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. 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 Medical Center when meeting with pharmaceutical companies, participating in 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).
Essential Job 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.
Ability to identify areas of project interest and interact with appropriate support group: SPIN, IRB, Tech Transfer
Completes forms and generates all reports required 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 efficiency of the internal controls within the unit and compliance with organizational policies and procedures.
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.
Department Specific Responsibilities
The Regulatory Coordinator III will be responsible for the oversight and coordination of regulatory aspects for all projects that are managed by the Translational Research Concierge (TRC) group. Responsibilities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the IRB, FDA and other ancillary committees including, Protocol Review and Monitoring Committee (PRMC). The RAC III helps with effectively steering protocols through the regulatory committee process in a timely manner to ensure a prompt activation of trials and for all regulatory aspects of the protocols assigned. In addition, the RAC III serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies, and other research entities. The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore).
Ability to work with deadline driven structure and demonstrated experience in maintaining flexibility and adaptability while implementing institutional change. Ability to take initiative and demonstrate strong commitment to duties with a high level of integrity in compliance with regulatory management
Develop Standard Operating Procedures for the TRC support group.
Bachelor's Degree, minimum.
Certification of Clinical Research Professional, preferred.
Five (5) years of directly related experience, minimum.
Working Title: Regulatory Coordinator III - Translational Research Concierge
Department: Cancer Institute
Business Entity: Academic / Research
City: West Hollywood
Job Category: Family & Function, Academic / Research
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major t...eaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.