Clinical Research Coordinator RN II
Newport Beach, California
Hoag Hospital Newport Beach

Job Opportunity: Clinical Research Coordinator - RN II

Location: Newport Beach, California
Employment Type: Direct Hire

Job Summary

The Clinical Research Coordinator - Registered Nurse II (CRC RN-II) manages all aspects of complex clinical research trials, including drug, device, and biologic studies across all phases (I-IV), government-funded research, and investigator-initiated studies. The role ensures compliance with Good Clinical Practice standards, human subject protection regulations, and FDA guidelines.

Key Responsibilities

• Manage complex clinical research trials (industry-sponsored, government-funded, investigator-initiated).
• Ensure compliance with Good Clinical Practices, FDA regulations, and human subject protection standards.
• Provide study management, coordination, and operational support.
• Review and prepare protocols prior to study initiation.
• Administer and manage the informed consent process per regulatory requirements.
• Conduct subject recruitment, screening, and eligibility assessments.
• Collect, process, and document laboratory samples following International Air Transport Association standards.
• Complete all protocol-required clinical assessments and procedures.
• Accurately collect, record, and enter study data, maintaining data integrity and quality.
• Complete case report forms and address data queries promptly.
• Monitor and report adverse events according to protocol and regulations.
• Maintain regulatory binders and study documentation per sponsor and regulatory standards.
• Develop study flow sheets and prepare source documentation.
• Participate in study team meetings and site initiation visits.
• Assist with cost analysis, budget preparation, and study fund tracking.
• Support growth and strategic vision of the research institute.
• Assist with training and mentoring other Clinical Research Coordinators.
• Promote team building and a positive work environment.

Contract Length

• 13 weeks

Required Skills & Experience

• Minimum 2 years of clinical research experience or equivalent training.
• Knowledge of Good Clinical Practices, human subject protection, and FDA regulatory guidelines.
• Excellent verbal and written communication skills.
• Strong organizational skills and attention to detail.
• Excellent interpersonal skills for effective teamwork in a diverse environment.
• Strong analytical and problem-solving abilities.
• Proficiency in Microsoft Word, PowerPoint, and Windows applications.
• Ability to work effectively in a fast-paced, team-based environment.
• Project management and coordination skills with ability to prioritize and meet deadlines.
• Ability to establish cooperative working relationships with patients, physicians, and coworkers.
• Professional behavior and promotion of team-building.
• Ability to follow organizational and departmental policies and procedures.
• Ability to travel locally between organization locations as required.

Preferred Skills & Experience

• Working knowledge of FDA, NIH, and OHRP regulatory requirements.
• Familiarity with ICH Good Clinical Practice guidelines.
• Understanding of clinical trial methodologies.
• Experience filing Institutional Review Board (IRB) documentation.
• Ability to abstract data from medical records into data collection forms or electronic databases.

Education Requirements

• Required: High School Diploma
• Preferred: Bachelor of Science in Nursing (BSN) or higher

Certifications & Licensure

• Required:

  • Current Registered Nurse licensure in California (in good standing)
  • Basic Life Support (BLS) Certification
• Preferred:

  • ACRP or SoCRA Certification
  • Nursing Specialty Certification
  • International Air Transport Association (IATA) Certification

Prior Travel Experience

• Not required for this position.