Clinical Research Associate

The Clinical Research Associate (CRA) is responsible for ensuring the successful and sustainable execution of clinical trials at the site level. This includes performing on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials in compliance with monitoring procedures, ICH / GCP guidelines, local regulations, and SOPs.

The CRA proactively manages site performance, focusing on recruitment and quality, and is the primary point of contact for site-related issues and needs, both internally and externally.

About the Role

Key Responsibilities:

• Act as the frontline liaison between Novartis and study sites to ensure successful collaboration and achievement of milestones and deliverables with a strong ownership mindset.
• Manage assigned study sites, conducting 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 and re-training as needed.
• Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocols, ICH / GCP, and all relevant regulations, with proper documentation.
• Identify deficiencies in site processes, collaborate on risk mitigation and process improvements, and promote a culture of compliance and ethical integrity.
• Establish strong partnerships with sites to improve patient recruitment and reduce issues.
• Engage early with sites on patient inventory and flow planning prior to SIVs.
• Perform Site Closeout activities, ensuring proper follow-up and archiving.
• Collaborate with project managers, MSLs, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
• Participate in audit and inspection readiness activities, ensuring timely implementation of corrective actions.

Qualifications:

• Degree in Scientific disciplines.
• At least 1 year of 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? We aim to reimagine medicine to improve and extend lives. Our people are our strength. Join us and be part of our mission to make a difference.