The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at the site level. Responsibilities include on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, in compliance with monitoring procedures, ICH / GCP guidelines, local regulations, and SOPs.The CRA proactively manages site performance (recruitment and quality), identifies site needs and issues early, and acts as the primary point of contact (both internally and externally) for all sites.About the RoleKey Responsibilities:Serve 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, ensure site personnel are trained on trial 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 process deficiencies, collaborate with sites on risk mitigation and process improvements.Promote a culture of compliance, human subject protection, and data integrity.Establish strong partnerships with sites to increase patient recruitment and reduce issues.Engage early with sites on patient inventory and flow, collaborating with the global and local study teams.Perform Site Closeout activities per SOPs and regulations, ensuring proper documentation and archiving.Collaborate with the Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.Participate in audit and inspection readiness activities, implementing corrective actions as needed.Requirements include a degree in scientific disciplines, at least 1 year of CRA experience in pharma or CRO, fluency in Italian, good knowledge of English (B2), and willingness to travel across Italy.Why Novartis?Our purpose is to reimagine medicine to improve and extend lives. We value our people, who drive us toward our goals. Join us to be part of this mission! Learn more about our benefits, rewards, and commitment to diversity and inclusion.Join Our NetworkIf this role isn't a perfect fit, stay connected by joining the Novartis Network or our talent community to learn about future opportunities.
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