CRA (Level II)
Core
Monitoring clinical trial sites in Italy to ensure compliance with protocols, ICH-GCP guidelines, and regulations while ensuring subject safety and data integrity.
Role type
Clinical Research Associate II (CRA II)
Builds
Clinical trial data and regulatory compliance for pharmaceutical/biotech studies
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, ICH-GCP guidelines, Source Data Verification (SDV), Risk-Based Monitoring (RBM), Investigational product accountability, Root cause analysis, CAPA implementation, Clinical trial management systems (CTMS)
Preferred skills
Medical terminology, Analytical thinking, Problem-solving, Planning and organization
Technologies
Microsoft Office, Clinical trial management systems (CTMS)
Responsibilities
Conduct on-site and remote monitoring visits; Perform Source Data Verification and review; Assess investigational product accountability; Identify site issues and implement corrective actions; Prepare monitoring reports; Support site initiation, routine, and close-out visits; Maintain study documentation.
Seniority
Junior to Mid-level, hands-on IC