Part‑time Clinical Research Nurse (24 hrs/week)

About the role

The Clinical Research Nurse will support multiple ongoing clinical trials, ensuring patient safety and data integrity. Working 24 hours per week in an office environment, you will coordinate study activities from recruitment through retention.

Key responsibilities

• Conduct clinical studies in compliance with FDA, GCP, and ICH regulations.
• Provide direct medical care to participants, including vital signs, ECGs, blood draws, and pregnancy testing.
• Schedule subject visits within protocol windows and maximize site capacity.
• Complete informed consent, screening, and all protocol‑specified procedures.
• Document patient information, test results, and adverse events on required forms and electronic systems.
• Maintain investigational product accountability logs when required.
• Ensure IRB approval is obtained and maintained throughout each study.
• Serve as primary sponsor contact, liaise with monitors, and attend site initiation meetings.
• Train and mentor junior team members and act as backup manager when needed.

Required profile

• Registered Nurse with experience in clinical research or trial coordination.
• Strong understanding of FDA, GCP, ICH, and IRB processes.
• Excellent attention to detail and ability to manage multiple studies simultaneously.
• Effective communication skills for interacting with participants, sponsors, and internal staff.

Required skills

• FDA/GCP compliance
• ICH guideline implementation
• IRB submission and maintenance
• Adverse event reporting
• Clinical data collection and documentation
• Investigational product accountability