Clinical Research Coordinator - RN II

Clinical Research Coordinator – RN II

Location: Newport Beach, CA
Salary: $52 – $75 per hour Based on the years of experience
Job Type: Direct Hire | Full-Time | Onsite

Position Overview:

We are seeking a Clinical Research Coordinator – RN II to manage and coordinate complex clinical research trials including drug, device, and biologic studies across Phase I–IV trials. This role works closely with physicians, sponsors, and research teams to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and human subject protection standards.

Schedule: Full-Time Mon – Fri 8:30 AM – 5:00 PM

Key Responsibilities:

• Manage and coordinate complex clinical research trials including industry-sponsored, government-funded, and investigator-initiated studies.
• Conduct protocol review and study preparation prior to trial initiation.
• Manage the informed consent process according to regulatory standards.
• Recruit, screen, and assess study participants based on eligibility criteria.
• Collect and process laboratory samples in compliance with IATA standards.

Required Qualifications:

• 2+ years of clinical research experience or equivalent training
• Active Registered Nurse (RN) license – California
• Basic Life Support (BLS) Certification
• Knowledge of Good Clinical Practices (GCP), FDA regulations, and human subject protection
• Strong organizational, analytical, and communication skills
• Proficiency in Microsoft Word, PowerPoint, and Windows applications
• Ability to work in a fast-paced research environment

Preferred Qualifications:

• Bachelor of Science in Nursing (BSN)
• Knowledge of FDA, NIH, and OHRP regulatory requirements
• Experience with Institutional Review Board (IRB) documentation
• Understanding of clinical trial methodologies
• ACRP or SoCRA certification
• IATA certification