Clinical Research Coordinator-256742

About the RoleWe are seeking a detail-oriented Clinical Research Coordinator to coordinate trials from site initiation to study close-out, ensuring strict adherence to regulatory standards while delivering top-tier participant care and maintaining data integrity.Key ResponsibilitiesCoordinate all phases of assigned clinical trials from site initiation through study close-out.Conduct subject visits and execute study procedures (e.g., phlebotomy, ECGs, sample processing) within scope of training.Ensure timely, accurate documentation following ALCOA-C standards.Manage subject recruitment, informed consent processes, and retention strategies.Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and SOPs.Manage timely data entry into EDC systems and resolve queries promptly.Report and follow up on all adverse events (AEs), serious adverse events (SAEs), and protocol deviations.Collaborate closely with investigators, lab teams, sponsors/CROs, and internal stakeholders.Prepare for and participate in monitoring visits, audits, and regulatory inspections.Maintain regulatory documentation, study manuals, equipment calibration, and inventory control.RequirementsHigh school diploma or GED.At least 1 year of experience as a Clinical Research Coordinator OR at least 2 years of experience as a Clinical Research Assistant.Deep understanding of FDA regulations, ICH-GCP guidelines, and clinical trial procedures.Strong proficiency in medical terminology and clinical documentation practices.Preferred QualificationsBilingual in English and Spanish.Outstanding interpersonal, verbal, and written communication skills.Highly organized with strong multi-tasking capabilities and detail orientation.Proficiency in Microsoft Office Suite and standard clinical research electronic systems.