Clinical Research Associate

The Clinical Research Associate (CRA) ensures the sustainable execution of 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 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 aspects, and providing ongoing training and re-training as needed.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identifying deficiencies in site processes and collaborating with sites on risk mitigation and process improvements.
• Promoting a culture of compliance and ethical integrity, safeguarding human subjects, and ensuring reliable trial results.
• Establishing strong partnerships with sites to enhance 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, including follow-up and archiving.
• Collaborating with project managers, medical staff, and other stakeholders to optimize recruitment, site development, and data quality.
• Participating in audit and inspection readiness activities, implementing corrective actions as needed.

Qualifications

• Degree in Scientific disciplines.
• At least 1-year experience as a CRA in a pharmaceutical company or CRO.
• Fluent in Italian; 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 people, who drive us toward our ambitions. Join us and be part of this mission! Learn more about our benefits and diversity initiatives.