CRA - MONITOR

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80llvp

Overview In this role you support multicenter clinical studies by monitoring sites to ensure protocol adherence and data reporting per GCP/ICH guidelines. You will drive site communication, training, and recruitment alignment to project needs, and manage study progress and documentation in collaboration with the study team. Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements (GCP/ICH) Administer protocol training to sites and maintain regular communication on project expectations Track regulatory submissions, approvals, recruitment, CRF completion, data query handling; Maintain Trial Master File and Investigator's Site File per GCP/ICH and local regs Document site management activities, visit findings,



and action plans; prepare visit reports and follow-up letters Collaborate with study team for project execution; may support site recruitment plan development and invoice retrieval as applicable CRA certification according to Ministerial requirements CRA training or prior monitoring experience Basic knowledge of GCP/ICH regulations Good therapeutic and protocol knowledge (training provided) MS Office skills (Word, Excel, PowerPoint); laptop and mobile devices usage Strong written and spoken English Time and financial management skills time management GCP/ICH regulatory knowledge site monitoring and data integrity

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/80llvp