CRA II/ Senior CRA I - Future Roles (Italy)
Core
Clinical Research Associate performing site qualification, monitoring, and management to ensure regulatory compliance and data integrity in clinical trials.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory compliance
Domain
Biopharmaceuticals / Clinical Research
Required skills
Site qualification, Source Document Review, Case Report Form verification, Investigational Product management, Audit readiness, Protocol compliance, Data entry, Site recruitment support
Preferred skills
Real World Late Phase study design knowledge, Chart abstraction, Local market knowledge for site identification
Technologies
Electronic Data Capture (EDC) systems, Tracking systems
Responsibilities
Perform site qualification, initiation, interim monitoring, and close-out visits; Verify informed consent and protect subject confidentiality; Conduct Source Document Review and verify CRF data accuracy; Manage Investigational Product inventory and administration; Review Investigator Site File and ensure archiving compliance; Support subject recruitment and retention; Prepare for and attend Investigator Meetings; Provide guidance on audit readiness.
Seniority
Mid-level (CRA II) to Senior (CRA I)