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Hoag Health System · 3 weeks ago

Clinical Research Coordinator (RN): Cancer Research

2975 Red Hill Ave, Costa Mesa, CA, 92626, US

Full-time

Onsite

Mid Level

$51.59/hr - $79.73/hr

Hoag Health System is a healthcare organization dedicated to providing quality care, and they are seeking a Clinical Research Coordinator RN for their cancer research initiatives. The role involves overseeing all aspects of clinical research activities, ensuring compliance with FDA regulations, and collaborating with study physicians throughout the research process.

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

Clinical Research CoordinationFDA Regulatory KnowledgeInformed Consent AdministrationData CollectionAdverse Event ReportingBudget PreparationSubject RecruitmentTeam Collaboration