Clinical Research Coordinator
On-site · Chesterfield, Missouri, United States
Job Summary
Clinical Research Coordinator at Headlands Research onsite in Chesterfield, MO, responsible for coordinating all aspects of assigned clinical trials from site initiation to study close-out. Conduct subject visits, 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; ensure timely data entry and resolution of EDC queries; report adverse events and deviations; collaborate with investigators, sponsors/CROs, and internal stakeholders; prepare for and participate in monitoring visits, audits, and inspections; maintain regulatory documentation and ensure training for amendments and systems; execute study procedures such as phlebotomy and ECGs; attend investigator meetings and provide cross-functional support; maintain knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control.
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
- 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
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