Cedars-Sinai Regulatory Coordinator II - Cancer Clinical Trials Office in Beverly Hills, California
Do you have a passion for helping human kind?
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:
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.
Three (3) years minimum of directly related experience, required
BA/BS degree, required
Specialty research certification, preferred.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.