Clinical Trials Lead Site Coordinator
Core
Act as the main line of communication between the Sponsor/CRO and the site to support trial activities, monitoring visits, and patient enrollment.
Role type
Clinical Trials Lead Site Coordinator
Builds
Clinical trial operations at medical institutions/research centers
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
Pharmacy, nursing, or lab analytics background, global team collaboration, problem-solving in stressful situations
Technologies
EDC systems
Responsibilities
Act as main communication line between Sponsor/CRO and site; Ensure timely response to feasibility questions; Assist in scheduling and preparation for monitoring visits; Track patient enrollment; Maintain study-specific document tracking; Perform accurate data entry into EDC systems; Report and follow up on Adverse Events and Protocol Deviations; Handle investigational products and clinical supplies; Collect and maintain site-specific regulatory documents; Facilitate contract and budget negotiations; Support Investigator and Site payments; Schedule and perform study procedures; Prepare for onsite audits or regulatory inspections.
Seniority
Mid-level, hands-on IC