Clinical Research Coordinator II (RN): Cell Therapy Research

Job Description

This position requires to be on-site.

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.

Qualifications

Education and Experience

• 3-4 years 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
• 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

About Us

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.

Hoag offers a comprehensive blend of health care services including six institutes providing specialized care in the areas of cancer, heart and vascular, neurosciences, women's health, orthopedics, and digestive health through our institutes.

Hoag was the highest ranked hospital in Orange County in the 2024-2025 U.S. News &World Report, the only Orange County hospital ranked in the top 10 for California. The organization was ranked the #5 hospital in the Los Angeles Metro Area and the #10 hospital in California.

To learn more about Hoag's awards and accreditations, visit:

Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.

Job Info

• Job Identification 127475
• Job Category Research
• Locations 1 Hoag Dr, Newport Beach, CA, 92663, US
• Remote or Onsite Onsite
• Job Schedule Full Time