Senior CRA II - Future Roles (Italy)
Core
Conducts site qualification, initiation, monitoring, and close-out visits to ensure regulatory compliance and data integrity for clinical trials.
Role type
Senior Clinical Research Associate II (Site Management)
Builds
Clinical study data and patient safety outcomes
Domain
Biopharmaceuticals / Clinical Research
Required skills
ICH-GCP knowledge, source document review, informed consent verification, investigational product management, audit readiness, site recruitment support, travel management
Preferred skills
Real World Late Phase study design, chart abstraction, RFP development, site management strategy
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 reviews and CRF data verification; manage investigational product inventory and administration; review Investigator Site Files; document activities via trip reports and logs; support subject recruitment and retention; manage site-level communication and timelines; provide mentorship to junior CRAs; participate in bid defense meetings and RFP development for Real World Late Phase studies.
Seniority
Senior, hands-on IC
