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Hoag Health System · 1 month ago

Clinical Research Coordinator (RN): Molecular Therapy

One Hoag Drive, Newport Beach, CA, 92658, US

Full-time

Onsite

Mid Level

$49.15/hr - $75.94/hr

Hoag Health System is a healthcare organization seeking a Clinical Research Coordinator (RN) for their Molecular Therapy division. The role involves managing all aspects of clinical research activities, ensuring compliance with FDA regulations, and coordinating with study physicians throughout the clinical trial process.

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

Clinical research coordinationFDA regulations knowledgeInformed consent administrationData collectionRegulatory complianceSubject recruitmentAdverse event reportingTeam collaboration