Cedars-Sinai Regulatory Coordinator II - Cancer Clinical Trials Office in Los Angeles, California
Expand your career at Cedars-Sinai!
The Cedars-Sinai Cancer Research Team is committed to pursuing pioneering research into disease method, diagnostic innovations, new technologies, and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.
Join our team and use your skills with an organization known nationally for excellence in cancer research!
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 research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing Cedars-Sinai when meeting with pharmaceutical companies, collaborating during weekly team meetings, and working with other staff to ensure all documentation and requirements are met and current. The incumbent may coordinate strategies for improving efficiency, action plans to improve quality, and mentor team members.
Essential Job Duties and Responsibilities:
Prepares and submits protocols and supporting documents to internal or external regulatory bodies.
Submits study continuations and amendments as needed to maintain compliance with regulatory and institutional requirements.
Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
Establishes and maintains critical documentation pertaining to regulatory requirements for clinical trials.
Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
Works with the clinical trial coordinator, research staff, and investigators to ensure that all regulatory documents for the research studies are current.
Participates in weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
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.
Department and/or Unit Specific – Essential Job Responsibilities:
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.
- BA/BS degree.
- ACRP/SoCRA (or equivalent) certification preferred.
- Three (3) years minimum of directly related experience, or equivalent combination of education and experience.
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.