Job Title: Clinical Research Coordinator (RN)

Location: Irvine, California

Duties: Coordinate and oversee all aspects of clinical research activities. Work closely with study physicians and ensure compliance with FDA regulations for drug/device/biologic studies. Manage the process of clinical studies from planning and approval to completion and closure. Responsibilities:

Provide leadership and support for Phase I-IV clinical trials and other research initiatives. Ensure accurate and efficient progression of clinical studies. Uphold strict adherence to regulatory requirements and guidelines.

Required Skills & Experience: High attention to detail and precision in following instructions. At least one year of experience as a Clinical Research Coordinator or five years in the relevant medical specialty. Proficient in medical terminology. Knowledgeable in FDA, NIH, OHRP regulatory requirements, and ICH GCP guidelines.

Education: Minimum: High School Diploma or GED. Preferred: Bachelor of Science in Nursing (BSN).

Required Certifications & Licensure: Current RN license in good standing in the State of California. Either currently holds or will obtain a Certified Clinical Research Coordinator Certificate (ACRP or SoCRA) within 2 years of hire. BLS-AHS certification required. Must maintain all current licenses, certifications, and registrations.

Compensation: $70