Ph3Experteer Overview /h3pAs 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. /ph3Retribuzione / Benefits /h3ulliAct as Parexel's direct site contact and safeguard study integrity /liliBuild and maintain relationships with investigators and site staff /liliFacilitate site access to study systems and ensure training compliance /liliAssess and adjust site staff assignments and provide corrective actions /liliAddress site issues, including training gaps and documentation deficiencies /liliParticipate in meetings, audits, and inspections as required /liliEvaluate and support site recruitment plans and strategies /liliConduct on-site and remote visits, document findings, and follow up /liliMonitor data quality, query resolution, and SAE follow-up /liliEnsure trial management systems (CTMS, EDC, IVRS, SIS) are updated timely /liliManage supply/return of study articles and site payments /liliProvide site training and facilities assessments as applicable /liliCommunicate study issues and propose resolutions to timelines and patient safety /liliMaintain audit/inspection readiness and regulatory compliance /liliDevelop SME expertise and work in a self‑driven, team‑oriented environment /liliOversee TMF documentation and first‑time quality across sites /liliSupport performance development conversations and manager updates /li /ulh3Responsabilità /h3ulliClose to 2 years of independent monitoring experience in a similar setting /liliSite management experience or equivalent clinical research background /liliEducated to degree level in a health‑related discipline (preferred) /liliAbility to travel extensively within Italy /liliKnowledge of ICH‑GCP and applicable regulations /liliProficiency with CTMS, EDC, IVRS, and EDMS systems /liliStrong problem‑solving, communication, and interpersonal skills /li /ulh3Requisiti fondamentali /h3 /p #J-18808-Ljbffr