Hoag Health System · 1 month ago
Clinical Research Coordinator II (RN): Cell Therapy Research
One Hoag Drive, Newport Beach, CA, 92658, US
Full-time
Onsite
Mid Level
3+ years expHoag Health System is a nonprofit regional health care delivery network in Orange County, California, and they are seeking a Clinical Research Coordinator II (RN) to oversee clinical research activities. The role involves coordinating FDA regulated research, managing clinical trials, and ensuring compliance with regulatory guidelines while supporting study physicians and research participants.
Hospital & Health Care
Responsibilities
Responsible for all aspects of clinical research activities and works in close cooperation with study physicians
Provides support, coordination and leadership for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research
Ensures smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure
Involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders
Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects
Assists in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds
Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing and close-out visits
Maintains knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research
Qualification
Required
3-4 years of Clinical Research Coordinator experience or at least three years of experience in the specific medical specialty of the position
Patient coordination experience in complex clinical trial setting required
Medical terminology required
Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines
Understanding of clinical trial methodologies and experience filing Institutional Review Board documents
Current licensure in good standing as a Registered Nurse in the State of California
Preferred
Bachelor of Science in Nursing (BSN) preferred
Familiar with the medical area of neurosciences particularly in the areas of stroke, epilepsy, movement disorders and cognitive disease preferred
Holds current Certified Clinical Research Coordinator certificate (ACRP or SoCRA), or complete within two years of hire
Maintain CPR, certifications (BLS, ACLS, NALS, PALS, E.P., etc.) as applicable per hospital policy
Company
Hoag Health System
Hoag is a nonprofit, regional health care delivery system in Orange County, California.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Robert Braithwaite
President and Chief Executive Officer
Eric Cheung
Chief Legal Officer, General Counsel, Senior Vice President
Recent News
PR Newswire
2025-07-14
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