Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab
Los Angeles, California
Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. By joining us in an academic role, you’ll be a part of formulating future ideas for discovery and then translating those discoveries into cures for the benefit and health of the Los Angeles community.
- Full-time & Per-Diem
- Level: Mid to Senior
- Travel: Minimal (if any)
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What makes a successful Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab at Cedars-Sinai? Check out the traits we’re looking for and see if you have the right mix.
Discovery is central to Cedars-Sinai’s mission. Our laboratories and clinics generate ideas, therapies, devices, and systems that contribute to biomedical progress around the world. Cedars-Sinai’s investigators push the frontiers of biomedicine with studies in cardiac care, cancer, digestive health, the neurosciences, women’s health, and more. Cedars-Sinai’s robust academic enterprise shapes the experts who will help redefine medicine for the next generation.
ResponsibilitiesRequisition # 20003512
- 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.
- 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
- Working Title: Regulatory Coordinator I - Smidt Heart Institute - Cheng Lab
- Department: Heart Institute Operations
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic/Research
- Job Specialty: Research Studies/Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
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