Clinical Research Coordinator

Responsibilities

• Coordinate all aspects of assigned clinical trials from site initiation through close-out
• Conduct subject visits and ensure accurate, timely documentation in compliance with ALCOA-C standards
• Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs
• Manage subject recruitment, informed consent, and retention activities
• Ensure timely EDC data entry and resolution of queries
• Report and follow up on AEs, SAEs, and protocol deviations
• Collaborate with investigators, sponsors/CROs, labs, and internal teams
• Prepare for and participate in monitoring visits, audits, and inspections
• Maintain regulatory documentation and ensure training compliance
• Perform study procedures such as phlebotomy, ECGs, and sample processing

Requirements

• High school diploma or GED required; Bachelor’s degree preferred
• At least one full year of experience coordinating multiple Phase 2–4 industry-sponsored clinical trials
• Experience with regulatory, patient visits, consenting, and interacting with sponsors
• Experience with EDC, IVRS, and clinical research platforms
• Strong understanding of FDA regulations and ICH-GCP
• Proficiency in medical terminology and clinical documentation
• Trained and experienced in phlebotomy preferred

About the Company

Peninsula Research Associates (PRA) is a site within the Headlands Research network, dedicated to advancing medical treatments through innovative clinical research in areas such as allergy, asthma, vaccines, and immunology.