Senior Clinical Research Coordinator

Responsibilities

• Provide the highest level of care for study patients
• Coordinate all aspects of assigned clinical trials from site initiation through close-out
• Conduct subject visits and ensure accurate, timely documentation in compliance with protocol and 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
• Perform study procedures such as phlebotomy, ECGs, and sample processing

Requirements

• At least two years of experience managing multiple phase 2-4 industry-sponsored clinical trial studies
• Bachelor's degree OR 2 years of college in a health-related program OR equivalent clinical trial training
• Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations
• Experience with EDC, IVRS, and clinical research platforms
• Proficiency in medical terminology and clinical documentation
• Strong organizational and communication skills

About the Company

Headlands Research AMCR Institute is dedicated to advancing metabolic and immunologic research through patient-centered, high-quality clinical trials. The site conducts studies focused on pre-diabetes, type 1 and type 2 diabetes, obesity, NAFLD/MASH, and vaccines.