Clinical Research Coordinator II

Responsibilities

• Provide high-level care for study patients and deliver excellent service to pharmaceutical clients
• 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
• Maintain regulatory documentation and ensure training compliance
• Perform study procedures such as phlebotomy, ECGs, and sample processing
• Mentor and coach site staff to enhance quality

Requirements

• 4-5 years of experience managing multiple phase 2-4 industry-sponsored clinical trial studies as primary coordinator
• Bachelor's degree, 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
• Ability to work onsite in a collaborative clinical environment

About the Company

Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery. Founded in 2018, the company operates over 20 sites across the US and Canada, leveraging cutting-edge technology to broaden outreach and participation in medical research.