Hoag Health System · 1 month ago
Clinical Research Coordinator (RN): Cardiac
One Hoag Drive, Newport Beach, CA, 92658, US
Full-time
Onsite
Mid Level
$49.15/hr - $75.94/hrHoag Health System is a healthcare organization seeking a Clinical Research Coordinator RN for their cardiac research initiatives. The role involves overseeing all aspects of clinical research activities, ensuring compliance with regulatory standards, and collaborating closely with study physicians.
Hospital & Health Care
Responsibilities
The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities and works in close cooperation with study physicians
The CRC-RN 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
The CRC-RN ensures smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure
This position reports to the Director of Clinical Research
The CRC-RN is 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
The CRC-RN 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
This position reports to the Director of Clinical Research and works as a team member to support growth and vision of the Hoag Institute for Research and Education
Qualification
Required
Registered Nurse (RN) license
Experience in clinical research activities
Knowledge of FDA regulated research including drug/device/biologic studies
Ability to coordinate and lead clinical trials
Experience with protocol review and informed consent administration
Familiarity with Institutional Review Board submission processes
Skills in subject recruitment and data collection
Experience with adverse event reporting and regulatory binder maintenance
Ability to develop cost analysis and study budgets
Knowledge of Good Clinical Practices and FDA regulatory guidelines
Company
Hoag Health System
Hoag is a nonprofit, regional health care delivery system in Orange County, California.
Founded in 1952
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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