Clinical Research Coordinator (RN): Molecular Therapy

Primary Duties And 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.

Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute-care hospitals with sixteen urgent care centers, eleven health centers and a network of more than1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers. More than 30,000 inpatients and 550,000 outpatients choose Hoag each year.

For over 70 years, Hoag has delivered a level of personalized care that is unsurpassed among Orange County’s health care providers. Since 1952, Hoag has served the local communities and continues its mission to provide the highest quality health care services through the core strategies of quality and service, people, physician partnerships, strategic growth, financial stewardship, community benefit and philanthropy.