pWe are partnering with a leading CRO to recruit both a bClinical Research Associate II /b and a bSenior Clinical Research Associate /b to support a growing portfolio of clinical studies across Italy. These are home-based positions covering sites primarily within Northern Italy, with an emphasis on high-quality site management and sponsor collaboration. /ppbr/ppThis is an excellent opportunity to join a collaborative clinical operations team working on innovative Phase I–IV studies across oncology. /ppbr/ppbKey Responsibilities /b /ppbr/pulliIndependently manage assigned investigative sites throughout the full clinical trial lifecycle. /liliConduct bSite Selection Visits (SSVs), Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) /b and bClose-Out Visits (COVs) /b. /liliEnsure studies are conducted in accordance with ICH-GCP, protocol requirements, SOPs and applicable regulatory guidelines.



/liliMaintain strong relationships with investigators, site staff and sponsor representatives. /liliPerform Source Data Verification (SDV) and Source Data Review (SDR) while ensuring high data quality. /liliIdentify, document and escalate protocol deviations and study risks where appropriate. /liliReview and maintain Investigator Site Files (ISFs), Trial Master Files (TMFs) and essential documentation. /liliSupport patient recruitment and retention strategies with investigative sites. /liliEnsure sites remain inspection and audit ready throughout the duration of the study. /liliWork collaboratively with Clinical Trial Managers, Project Managers and cross-functional teams to ensure successful study delivery. /li /ulpbr/p

📌 Clinical Research Associate II / Senior CRA (Macerata)
🏢 Barrington James
📍 Macerata