Clinical Research Associate

The Clinical Research Associate ensures the sustainable execution of trials at the site. 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 and processes in accordance with ICH / GCP, local regulations, and SOPs.

The role involves proactive site performance management (recruitment & quality), early identification of site needs and issues, and acting as the primary point of contact (internally & externally) for all sites.

About the Role

Key responsibilities include:

• Serving as the frontline liaison between Novartis and the sites to ensure successful collaboration, meeting milestones and deliverables with ownership mindset.
• Managing assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performing Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects, and providing ongoing training for amendments and new personnel.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identifying deficiencies in site processes, working closely with sites on risk mitigation and process improvements.
• Promoting a culture of compliance, adherence to high standards, and ethical integrity, ensuring human subject protection and reliable trial results.
• Establishing strong partnerships with sites to increase patient recruitment and reduce issues.
• Engaging early with sites on patient inventory and flow in collaboration with the global and local study teams.
• Performing Site Closeout activities per SOPs and regulations, ensuring proper follow-up and archiving.
• Collaborating proactively with the Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
• Participating in audit and inspection activities, ensuring corrective actions are implemented timely.
• Qualifications include a degree in Scientific disciplines, at least 1-year CRA experience in pharma or CRO, fluency in Italian, good English skills (B2), and willingness to travel across Italy.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend lives. We aim to be the most valued and trusted medicines company. Join us to be part of this mission. Learn more about our benefits and rewards in the Novartis Life Handbook. We are committed to diversity and inclusion, building an inclusive work environment.

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