FSP Clinical Research Associate I
Core
Performs and coordinates clinical monitoring and site management to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Clinical Research Associate I
Builds
Clinical trial sites and monitoring activities
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring, Source Data Verification (SDV), Root cause analysis, ICH-GCP compliance, Investigator site initiation, Trial close-out, Regulatory compliance, Data accuracy verification, Investigational product inventory
Preferred skills
Medical terminology, Clinical trial management systems (CTMS), Travel adaptability
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites with a risk-based approach; Conduct on-site and remote monitoring visits; Perform Source Data Review and Case Report Form review; Initiate and close-out clinical trial sites; Ensure audit readiness and regulatory compliance; Escalate and resolve site deficiencies; Manage investigator payments and trial materials.
Seniority
Entry-level, hands-on IC
