The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at the site level. 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 and quality) and identifies site needs and issues early. They serve as the primary point of contact (both 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 a mindset of ownership.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 fully trained on trial aspects, and provide ongoing training for amendments and new personnel.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 enhance patient recruitment and reduce issues.Engage early with sites on patient inventory and flow, collaborating with global and local teams.Perform Site Closeout activities per SOPs and regulations, ensuring proper archiving and follow-up.Collaborate with project managers, CRAs, MSLs, CRMA, and medical advisors to optimize recruitment, site development, and data quality.Participate in audit and inspection readiness activities, ensuring corrective actions are implemented timely.QualificationsDegree in Scientific disciplines.At least 1 year of experience as a CRA in a pharmaceutical company or CRO.Fluent in Italian and proficient in English (B2 level).Willingness to travel across Italy.Why Join Novartis?Our purpose is to reimagine medicine to improve and extend lives. We value our people, who drive us toward our ambitions. Join us to be part of this mission!Learn more about our benefits and commitment to diversity and inclusion in the Novartis Life Handbook. We are dedicated to building an inclusive, diverse work environment that reflects the communities we serve.Stay ConnectedIf this role isn't the right fit, join our Novartis Network to stay informed about future opportunities.Not the right role? Sign up for our talent community to receive updates on suitable positions as they become available.J-18808-LjbffrClinical Research Associate • Pistoia, Italy
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