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
• 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

Requirements

• Required: High school diploma or GED
• Experience: Minimum of 1 year of experience as a Clinical Research Coordinator OR Minimum of 2 years of experience 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
• Organized, detail-oriented, and capable of managing multiple priorities
• Proficient in Microsoft Office and other clinical research systems
• Bilingual (English/Spanish) is strongly preferred