Clinical Research Associate

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 and processes in accordance with ICH / GCP, local regulations, and SOPs.

The CRA proactively manages site performance (recruitment & quality) and identifies site needs and issues early. They serve as the primary point of contact (internally & externally) for all sites.

About the Role

Key responsibilities include, but are not limited to:

• Acting as the frontline liaison between Novartis and study sites to ensure successful collaboration, meeting milestones and deliverables with a true ownership mindset.
• Managing assigned study sites and conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performing Site Initiation Visits, ensuring site personnel are fully trained on trial-related aspects, and providing ongoing training and re-training as needed.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocols, ICH / GCP, regulations, and documentation standards.
• Identifying deficiencies in site processes, collaborating on risk mitigation and process improvements.
• Promoting a culture of compliance and ethical integrity, ensuring human subject protection and reliable trial results.
• Establishing strong partnerships with sites to increase patient enrollment and reduce issues.
• Engaging early with sites on patient inventory and flow in collaboration with global and local teams.
• Performing Site Closeout activities per SOPs and regulations, ensuring proper follow-up and archiving.
• Collaborating with project managers, MSLs, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
• Participating in audits and inspection readiness activities, implementing corrective actions as needed.

Minimum qualifications:

• Degree in scientific disciplines.
• At least 1 year of 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 value our associates who drive us toward our ambitions. Join us and be part of this mission! Learn more about our benefits and rewards in the Novartis Life Handbook and our commitment to diversity and inclusion.

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