The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at study sites. They perform on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, adhering to monitoring procedures, ICH / GCP guidelines, local regulations, and SOPs.The CRA proactively manages site performance (recruitment & quality), identifies site needs and issues early, and acts as the main point of contact internally and externally for all sites.About the RoleKey Responsibilities include, but are not limited to:Act as the frontline liaison between Novartis and study sites to ensure successful collaboration, meeting milestones and deliverables with ownership mindset.Manage assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.Perform Site Initiation Visits, training site personnel on trial-related aspects, and provide ongoing training and re-training as needed.Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocols, ICH / GCP, regulations, and documentation standards.Identify deficiencies in site processes, collaborate on risk mitigation, and implement process improvements.Promote a culture of compliance and ethical integrity, ensuring human subject protection and data reliability.Establish strong partnerships with sites to increase patient recruitment and reduce issues.Engage early with sites on patient inventory and flow in collaboration with the global and local study teams.Perform Site Closeout activities per SOPs and regulations, ensuring proper archiving and follow-up.Collaborate with the Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.Participate in audits and inspection readiness activities, ensuring timely implementation of corrective actions.Minimum QualificationsDegree in Scientific disciplines.At least 1-year experience as a CRA in a pharmaceutical company or CRO.Fluent in Italian and good knowledge of English (B2 level).Willingness to travel across Italy.Why Join Novartis?Our purpose is to reimagine medicine to improve and extend people’s lives. We aim to become the most valued and trusted medicines company in the world, driven by our people. Join us and be part of this mission! Learn more about our benefits and diversity initiatives in the Novartis Life Handbook.Connect with us through the Novartis Network to stay updated on opportunities or join our talent community if this role isn’t the right fit now.
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