Clinical Research Coordinator

Responsibilities

• Coordinate all aspects of assigned clinical trials from site initiation to study close-out
• Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards
• Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs
• Manage subject recruitment, informed consent, and retention strategies
• Ensure timely data entry and resolution of EDC queries
• Report and follow up on all adverse events, serious adverse events, and deviations
• Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders
• Prepare for and participate in monitoring visits, audits, and inspections
• Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems
• Execute study procedures such as phlebotomy, ECGs, and sample processing within scope
• Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control

Requirements

• Bachelor's degree OR 2 years of college in a health-related program
• Previous experience as a Clinical Research Coordinator required
• Experience and training in conducting clinical trials with knowledge of ICH GCP
• Familiarity with electronic data capture (EDC), IVRS, and other trial platforms
• Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures
• Proficiency in medical terminology and clinical documentation practices
• Strong interpersonal, verbal, and written communication skills
• Proficient in Microsoft Office and other clinical research systems

Preferred Qualifications

• Industry-sponsored trial experience
• Vaccine study experience

About the Company

Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery through cutting-edge technology and exceptional support services.