Cedars-Sinai Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab in Los Angeles, California
As a Regulatory Coordinator I, you will prepare and submit protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. You will submit 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 will 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Essential job duties and responsibilities:
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.
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:
Coordinates the administrative and office management system for the department/unit.
Maintains calendar of events and tracks deadlines, schedules meetings, makes travel arrangements, submits travel reimbursements.
Prepares and routes internal documents for signature processing.
May work with Principal Investigator to complete and submit federal and non-federal grants, including, contributing content to standard sections of grant applications.
May work as the liaison between department or research group and sponsored research funds administration, accounting, and finance departments.
May perform all Pre- and Post- grant award administrative functions.
May assist in the preparation and submission of documentation required for research compliance.
Assist senior level of research administrators and leadership on other activities as assigned.
- BA/BS degree required
- Specialty research certification preferred
- 1-2 years directly related 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.