04 ott - Italia
Iqvia
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
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