Clinical Research Coordinator
Core
Manages day-to-day operations of clinical research studies in the Department of Psychiatry, ensuring protocol fidelity, participant safety, and regulatory compliance for bipolar disorder research.
Role type
Clinical Research Coordinator
Builds
Clinical research studies and data sets
Domain
Healthcare / Clinical Research / Psychiatry
Required skills
ICH-GCP compliance, IRB/HIPAA regulations, EDC/CTMS systems, participant recruitment and screening, informed consent processes, adverse event reporting, data integrity management, regulatory documentation, stakeholder coordination
Preferred skills
Master's degree in nursing/allied health/psychology/neuroscience, phlebotomy competency, ECG competency, ACRP/SOCRA certification
Technologies
EDC, CTMS, EPIC research modules
Responsibilities
Coordinate study start-up, feasibility, and close-out activities; recruit, screen, and obtain informed consent from participants; schedule and conduct study visits including assessments and sample collection; monitor participant safety and report adverse events; maintain regulatory binders and submit IRB amendments; ensure data quality through source data verification; liaise with sponsors, CRAs, and ancillary departments.
Seniority
Mid-level, hands-on IC