Job Posting: 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, attending 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, action plans to 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). Summary of Essential Job Duties: - Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. - 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. - 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 weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments. - May 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. - May be required to develop clinical trial budgets. - Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. - 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.
Qualification Requirements/Preferences: Education Certifications/Licensure Experience Physical Abilities Experience: Three (3) years minimum of directly related experience, or equivalent combination of education and experience. Educational Requirements: -BA/BS degree required Certification: -ACRP/SoCRA (or equivalent) certification preferred. Physical Demands: (e.g., lifting, standing, walking) Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
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-scien...tists 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 teaching 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.