Clinical Research Coordinator

The role

The Clinical Research Coordinator will manage and execute Phase I-IV clinical studies. This role involves coordinating clinical trials from initiation to close-out and ensuring compliance with regulations and protocols.

What you will do

• 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 (as trained)

Required qualifications

• Bachelor's degree OR 2 years of college in a health-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required OR licensed as a Licensed Practical Nurs
• 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
• Organized, detail-oriented, and capable of managing multiple priorities
• Proficient in Microsoft Office and other clinical research systems

Nice to have

• Previous experience as a Clinical Research Coordinator preferred

Benefits

• Medical, dental, and vision insurance
• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
• Paid Time Off (PTO)
• Variety of disability, accident, and life insurance options
• 401(k) plan with company match
• Company holidays

About the company

Headlands Research is a leading network of advanced clinical trial sites founded in 2018. The company operates 20+ sites across the US and Canada.