Clinical Research Coordinator 257288

The Clinical Research Coordinator (CRC) manages the day-to-day operations of clinical research studies in compliance with study protocols, Good Clinical Practice (GCP) guidelines, and federal/institutional regulations. The CRC serves as a primary liaison between the Principal Investigator (PI), trial participants, sponsors, and the Institutional Review Board (IRB)
• Study Startup & Regulatory Compliance:
• Prepare and maintain regulatory documents, study binders, and IRB submissions/amendments.
• Coordinate sponsor visits, site initiation visits (SIVs), monitoring visits (IMVs), and audits.

Participant Recruitment & Informed Consent:
• Screen, identify, and recruit eligible trial subjects.
• Obtain and document informed consent under the guidance of the PI.

Study Visits & Clinical Procedures:
• Schedule and coordinate participant study visits from screening through closeout.

Data Management:
• Collect, record, and verify patient source documents and enter data into Electronic Data Capture (EDC) systems or Case Report Forms (CRFs).
• Resolve data queries and track adverse events