Clinical Research Coordinator (RN): Molecular Therapy

Hoag•Newport Beach, CA

About The Position

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.

Requirements

One year of Clinical Research Coordinator experience or at least three years of experience in the specific medical specialty of the position
Patient coordination experience in complex clinical trial setting 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
License Required: Current licensure in good standing as a Registered Nurse in the State of California

Nice To Haves

Familiar with the medical area of neurosciences particularly in the areas of stroke, epilepsy, movement disorders and cognitive disease 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

Responsibilities

Responsible for all aspects of clinical research activities
Provides support, coordination and leadership for FDA regulated 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
Assists 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
Works as a team member to support growth and vision of the Hoag Institute for Research and Education