Clinical Research Coordinator
Core
Manages day-to-day operations of clinical research studies to ensure protocol fidelity, participant safety, and regulatory compliance across start-up, conduct, and close-out phases.
Role type
Clinical Research Coordinator
Builds
Clinical research studies for academic and surgical departments
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
ICH-GCP compliance, participant recruitment and screening, informed consent administration, data entry and verification, regulatory documentation management, adverse event reporting, study start-up and close-out coordination
Preferred skills
Master's in Nursing or Allied Health, interventional trial experience, phlebotomy and ECG competencies, EDC/CTMS and Epic research module proficiency
Technologies
EDC/CTMS, Epic research modules
Responsibilities
Conduct pre-study feasibility and prepare start-up packages; recruit, screen, and obtain informed consent from participants; schedule and execute protocol-specified assessments; monitor participants for adverse events and report per protocol; maintain regulatory binders and submit amendments; perform source data verification and respond to sponsor queries; coordinate study close-out and archive records
Seniority
Mid-level, hands-on IC
