Experteer OverviewIn 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. The role includes ensuring TMF/ISF integrity, filtering quality issues, and possibly supporting start-up activities and site financials. You join a global, integrity-driven organization focused on advancing patient outcomes.Retribuzione / BenefitsPerform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements (GCP/ICH)Drive and track subject recruitment plans to improve predictabilityAdminister protocol training to sites and maintain regular communication on project expectationsAssess quality and integrity of site practices and elevate issuesTrack regulatory submissions, approvals, recruitment, CRF completion,



data query handling; may support start-upMaintain Trial Master File and Investigator's Site File per GCP/ICH and local regulationsDocument site management activities, visit findings, and action plans; prepare visit reports and follow-up lettersCollaborate with study team for project execution; may support site recruitment plan development and invoice retrieval as applicableResponsabilitàCRA certification according to Ministerial requirementsCRA training or prior monitoring experienceBasic knowledge of GCP/ICH regulationsGood therapeutic and protocol knowledge (training provided)MS Office skills (Word, Excel, PowerPoint); laptop and mobile devices usageStrong written and spoken EnglishOrganizational and problem-solving skillsTime and financial management skillsAbility to build effective working relationships#J-18808-Ljbffr

📌 Clinical Research Associate, Site Management - Italy (Milano)
🏢 Experteer Italy
📍 Milano