Site Coordinator
Core
Support clinical trial sites in all activities according to ICH-GCP and protocol requirements to meet enrollment goals.
Role type
Site Coordinator (Clinical Trials)
Builds
Clinical trial data and regulatory compliance for medical institutions
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
ICH-GCP compliance, patient enrollment tracking, EDC data entry, adverse event reporting, investigational product handling, regulatory document management, contract negotiation support, audit preparation
Preferred skills
Nephrology clinical study experience
Technologies
EDC systems
Responsibilities
Act as main communication line between Sponsor/CRO and site; assist in scheduling monitoring visits; track patient enrollment; maintain study documents; enter data into EDC systems; report adverse events and protocol deviations; handle investigational products; prepare for audits/inspections
Seniority
Mid-level, hands-on IC