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