Experteer OverviewAs a CRA II in Italy, you will be the primary contact for trial sites, driving initiation, recruitment, and quality assurance while ensuring compliance with GCP and regulations. You'll manage site performance, build strong investigator relationships, and troubleshoot issues to keep trials on track. This role supports cross‐country studies and requires travel; you'll partner with teams to deliver high‐quality data and patient safety. You'll shape site strategies within a mission‐driven, patient‐focused organization.Retribuzione / BenefitsAct as Parexel's direct site contact and safeguard study integrityBuild and maintain relationships with investigators and site staffFacilitate site access to study systems and ensure training complianceAssess and adjust site staff assignments and provide corrective actionsAddress site issues, including training gaps and documentation deficienciesParticipate in meetings, audits, and inspections as requiredEvaluate and support site recruitment plans and strategiesConduct on-site and remote visits, document findings, and follow upMonitor data quality, query resolution, and SAE follow-upEnsure trial management systems (CTMS, EDC, IVRS, SIS) are updated timelyManage supply/return of study articles and site paymentsProvide site training and facilities assessments as applicableCommunicate study issues and propose resolutions to timelines and patient safetyMaintain audit/inspection readiness and regulatory complianceDevelop SME expertise and work in a self‐driven, team‐oriented environmentOversee TMF documentation and first‐time quality across sitesSupport performance development conversations and manager updatesResponsabilitàClose to 2 years of independent monitoring experience in a similar settingSite management experience or equivalent clinical research backgroundEducated to degree level in a health‐related discipline (preferred)Ability to travel extensively within ItalyKnowledge of ICH‐GCP and applicable regulationsProficiency with CTMS, EDC, IVRS, and EDMS systemsStrong problem‐solving, communication, and interpersonal skillsRequisiti fondamentali
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