13 ott - Roma
Altro
Freelance Senior CRA - Italy | Oncology | 0.3-0.4 FTE
I'm currently supporting an international CRO looking for an experienced Freelance Senior CRA to provide support across an ongoing oncology study in Italy.
This 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.
The 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.
Key responsibilities
Independently manage assigned investigational sites in Italy
Conduct on-site and remote monitoring activities in line with the study monitoring plan
Build and maintain strong relationships with investigators, study coordinators and wider site teams
Complete monitoring visit reports accurately and within agreed timelines
Proactively manage outstanding site actions and follow-up through to resolution
Perform source data review/verification and ensure data quality and protocol compliance
Review essential documentation and support ongoing ISF/TMF completeness
Identify potential site-level risks and escalation issues appropriately
Support resolution of data queries, protocol deviations and monitoring findings
Ensure sites remain compliant with the protocol, ICH-GCP and applicable Italian/EU requirements
Maintain regular communication with the wider clinical study team regarding site progress, risks and outstanding actions
Support sites in maintaining ongoing inspection readiness
Requirements
Significant CRA/Senior CRA experience within Italy
Strong and recent oncology clinical trial experience is essential
Previous experience supporting ongoing Phase II/III studies would be highly desirable
Strong understanding of ICH-GCP and Italian/EU clinical trial requirements
Comfortable identifying and resolving site issues proactively
Fluent Italian and strong professional English
Available for approximately 0.3-0.4 FTE
Available to start ASAP
This would be particularly well suited to an established freelance CRA who has capacity alongside an existing project and is looking for a longer-term, tempo parziale oncology assignment.
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Intermedia Selection
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Acrobatica