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

• High school diploma or GED
• Minimum 1 year of experience as a Clinical Research Coordinator OR 2 years as a Research Assistant in Clinical Research
• 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 clinical research systems

Preferred Qualifications

• Bilingual (English/Spanish)

Benefits

• Competitive pay plus annual performance incentives
• Medical, dental, and vision insurance
• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
• 401(k) plan with company match
• Paid time off (PTO) and company holidays
• Disability, accident, and life insurance options

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.