Clinical Research Coordinator-256742

About the Role

We 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 Responsibilities

• Coordinate 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.

Requirements

• High 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 Qualifications

• Bilingual 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.