CRA - FSP - Italy
Core
Clinical Research Associate monitoring investigator sites for pharmaceutical and biotech sponsors to ensure protocol compliance and data accuracy.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for life science sponsors
Domain
Clinical Research / Life Sciences / Pharmaceuticals
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, data verification (SDR/SDV), ICH-GCP compliance, investigator site initiation, regulatory documentation
Preferred skills
Medical/therapeutic area knowledge, problem-solving, critical thinking, travel management
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through source data review; initiate and close out clinical trial sites; document observations and escalate deficiencies; participate in investigator meetings and payment processes; track trial status and update study systems.
Seniority
Mid-level, independent execution