Your responsibilities include, but are not limited to :
* Serve as the frontline liaison between Novartis and study sites to ensure successful collaboration, meeting Novartis expectations on milestones and deliverables with a true ownership mindset.
* Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
* Perform Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects. Provide ongoing training for amendments and new site personnel as required. Re-train site personnel as appropriate.
* Conduct continuous site monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, ICH / GCP, global and local regulations including Health Authorities, IRB / EC, data privacy requirements, and global / local processes as applicable. Document according to GDP and Novartis standards.
* Identify deficiencies in site processes and monitor site activities performed outside the site; collaborate closely with sites on risk mitigation and process improvements.
* Promote a culture of compliance, advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and the reliability of trial results at all times.
* Establish strong partnerships and true collaboration with sites to increase patient enrollment and reduce issues.
* Engage early with sites on patient inventory and patient flow in advance of SIV, in close collaboration with the global and local study teams.
* Perform Site Closeout activities per SOPs and applicable regulations, ensuring sites are aware of follow-up activities and archiving requirements.
* Collaborate proactively with the SSO Clinical Project Manager (CPM), CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
* Participate in audit organization and inspection readiness activities related to monitoring and site activities, ensuring timely implementation of corrective actions.
Qualifications :
* Degree in Scientific disciplines.
* At least 1 year of experience as a CRA in a pharmaceutical company or CRO.
* Fluent in Italian. Good knowledge of English (B2 level).
* Willing to travel across Italy.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. Achieving this depends on our people—our associates who drive us each day. Join us in this mission Learn more :
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J-18808-Ljbffr
Clinical Research Associate
• frosinone, Italia
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