Clinical Research Associate

The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at the site level. This role involves performing on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, in adherence to monitoring procedures, ICH/GCP guidelines, local regulations, and SOPs.

The CRA proactively manages site performance, focusing on recruitment and quality, and identifies site needs and issues early. The CRA serves as the primary point of contact internally and externally for all sites.

About the Role

Key Responsibilities:

• Act as the frontline liaison between Novartis and trial 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, ensuring site personnel are fully trained on trial aspects, and provide ongoing training for amendments and new staff.
• 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 reliable trial results.
• Establish strong partnerships with sites to enhance patient recruitment and issue resolution.
• Engage early with sites on patient inventory and flow, in collaboration with the global and local study teams.
• Perform Site Closeout activities following SOPs and regulations, ensuring proper archiving and follow-up.
• Collaborate proactively with project managers, medical staff, and other stakeholders to optimize recruitment, site development, and data quality.
• Participate in audit and inspection readiness activities, ensuring timely implementation of corrective actions.

Minimum Qualifications:

• Degree in Scientific disciplines.
• At least 1-year experience as a CRA in a pharmaceutical company or CRO.
• Fluent in Italian with good knowledge of English (B2 level).
• 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 to reach our ambitions. Join us and 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 that reflects the communities we serve.

If this role isn't suitable but you'd like to stay connected, join the Novartis Network or our talent community to learn about future opportunities.

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