Freelance Clinical Research Associate (0.4FTE)

pbFreelance Senior CRA - Italy | Oncology | 0.3-0.4 FTE /b /ppI’m currently supporting an international CRO looking for an experienced Freelance Senior CRA to provide support across an ongoing oncology study in Italy. /ppThis role requires someone who can come into an active study, quickly understand the current status of their sites and work with a high level of autonomy. /ppThe CRA will take ownership of assigned sites and be responsible for maintaining strong relationships with investigators and site teams, ensuring monitoring activities, documentation and follow-up actions are completed accurately and within required timelines. /ppbKey responsibilities: /b /pulliIndependently manage assigned investigational sites in Italy /liliConduct on-site and remote monitoring activities in line with the study monitoring plan /liliBuild and maintain strong relationships with investigators, study coordinators and wider site teams /liliComplete monitoring visit reports accurately and within agreed timelines /liliProactively manage outstanding site actions and follow-up through to resolution /liliPerform source data review/verification and ensure data quality and protocol compliance /liliReview essential documentation and support ongoing ISF/TMF completeness /liliIdentify potential site-level risks and escalation issues appropriately /liliSupport resolution of data queries, protocol deviations and monitoring findings /liliEnsure sites remain compliant with the protocol, ICH-GCP and applicable Italian/EU requirements /liliMaintain regular communication with the wider clinical study team regarding site progress, risks and outstanding actions /liliSupport sites in maintaining ongoing inspection readiness /li /ulpbRequirements: /b /pulliSignificant CRA/Senior CRA experience within Italy /liliStrong and recent oncology clinical trial experience is essential /liliPrevious experience supporting ongoing Phase II/III studies would be highly desirable /liliStrong understanding of ICH-GCP and Italian/EU clinical trial requirements /liliComfortable identifying and resolving site issues proactively /liliFluent Italian and strong professional English /liliAvailable for approximately 0.3-0.4 FTE /liliAvailable to start ASAP /li /ulpThis would be particularly well suited to an established freelance CRA who has capacity alongside an existing project and is looking for a longer-term, part-time oncology assignment. /p #J-18808-Ljbffr