Clinical Research Coordinator I

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
• Manage 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)
• Attend investigator meetings and provide cross-functional support as needed
• 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 OR experience and training in conducting clinical trials with knowledge of ICH GCP
• Previous experience as a Clinical Research Coordinator
• Industry-sponsored trial experience strongly preferred (vaccine study experience a plus)
• 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
• Organized, detail-oriented, and capable of managing multiple priorities
• Proficient in Microsoft Office and other clinical research systems

Benefits

• Competitive pay + annual performance incentives
• Medical, dental, and vision insurance
• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
• Paid time off (PTO) and company holidays
• A variety of disability, accident, and life insurance options
• A mission-driven culture focused on advancing medicine and improving patient outcomes