CRA (Level II)
Core
Monitor clinical trial sites in Italy to ensure compliance with protocols, ICH-GCP guidelines, and regulations, focusing on patient safety and data integrity.
Role type
Clinical Research Associate II (IC)
Builds
Clinical trials for pharmaceutical and biotechnology sponsors
Domain
Clinical research / Life Sciences
Deliverable
client delivery
Required skills
Clinical monitoring, ICH-GCP knowledge, Risk-Based Monitoring (RBM), Source Data Verification (SDV), Source Data Review (SDR), CRF review, 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 using RBM; Perform SDV, SDR, and CRF review; Assess investigational product accountability; Identify site issues and implement CAPA; Prepare monitoring reports; Support site initiation, routine, and close-out visits; Review essential documents; Maintain study documentation; Support audit readiness; Participate in investigator meetings.
Seniority
Junior to Mid-level, hands-on IC