Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements. Our researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves our cancer patients' treatment options, one trial at a time.
As the Regulatory Coordinator II, you will prepare and submit 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).
The Regulatory Coordinator department and/or unit specific job responsibilities are as follows:
Supports the Sponsor-Investigator (SPIN) Support Unit for the development and activation of investigator-initiated trials (IITs).
Responsible for drafting Informed Consent Forms (ICFs)/HIPAA(s) and completing the IRB application for clinical trials.
Facilitates IRB comments and requested revisions during IRB review of new study application and other IRB submissions.
Responsible for completing study amendments, continuing reviews, and reporting protocol deviations and safety reports to the IRB in a timely manner.
May attend Disease Research Group(s) (DRGs) meetings.
May provide training, mentorship and/or support to junior staff to ensure adequate regulatory compliance and critically evaluate incoming requests or issues.
Assist in maintenance of regulatory-related internal tracking databases and filing systems.
Assist in compilation of regulatory-related metrics for use by senior management.
Ensure all necessary forms are submitted to the trial sponsor and IRB.
Other duties as assigned by senior management.
Essential job 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 comply with regu
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.
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.
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.
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/
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 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.