Clinical Research Associate

The Clinical Research Associate (CRA) ensures the sustainable execution of clinical trials at the site level. The CRA performs 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:

• Act as the frontline liaison between Novartis and study 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 as needed.
• Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identify deficiencies in site processes, collaborate on risk mitigation and process improvements.
• Promote a culture of compliance and ethical integrity, ensuring human subject protection and data reliability.
• Establish strong partnerships with sites to increase patient enrollment and reduce issues.
• Engage early with sites on patient inventory and flow, collaborating with global and local teams.
• Perform Site Closeout activities per SOPs and regulations, ensuring proper archiving and follow-up.
• Collaborate proactively with project managers, MSLs, CRMA, and medical advisors to optimize recruitment and data quality.
• Participate in audit and inspection readiness activities, ensuring corrective actions are implemented timely.

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.

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