Hoag

Salary Range: $45.8900 - $70.5400 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.

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 assisting with monitoring, auditing, and close-out visits.
• Maintains knowledge of best practices 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 the growth and vision of the Hoag Institute for Research and Education.

Education and Experience

• One year of Clinical Research Coordinator experience or at least five years of experience in the specific medical specialty of the position
• Patient coordination experience in complex clinical trial settings 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
• 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.

License Required

• Current licensure in good standing as a Registered Nurse in the State of California.

Certifications 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