Clinical Research Coordinator - 119425

Provide the highest level of care for study patients Deliver excellent customer service to pharmaceutical clients Coordinate all aspects of assigned clinical trials from site initiation through close-out Conduct subject visits and ensure accurate, timely documentation in compliance with protocol and standards Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs Manage subject recruitment, informed consent, and retention activities Ensure timely EDC data entry and resolution of queries Report and follow up on AEs, SAEs, and protocol deviations Collaborate with investigators, sponsors/CROs, labs, and internal teams Prepare for and participate in monitoring visits, audits, and inspections Maintain regulatory documentation and ensure training compliance for amendments and systems Perform study procedures such as phlebotomy, ECGs, and sample processing (as trained) Attend investigator meetings and provide cross-functional support as needed Maintain working knowledge of protocols, lab manuals, equipment calibration, and inventory Requirements At least two years of experience managing multiple phase 2-4 industry-sponsored clinical trial studies as the primary coordinator required High school diploma or GED required Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations Experience with EDC, IVRS, and clinical research platforms Proficiency in medical terminology and clinical documentation Strong organizational skills with the ability to manage multiple studies Clear, professional verbal and written communication skills Comfortable working onsite in a collaborative, clinical environment #J-18808-Ljbffr Medix™