Clinical Research Associate

Novartis Farmacéutica; Latina; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Research Associate (CRA) to oversee the execution of clinical trials. The CRA will manage study sites, ensure compliance, and facilitate recruitment while promoting a culture of integrity. Ideal candidates have a scientific background, experience as a CRA, and are fluent in Italian.

Competenze

• At least 1 year of experience as a CRA in a pharmaceutical company or CRO.
• Fluent in Italian and proficient in English (B2 level).
• Willingness to travel across Italy.

Mansioni

• Act as liaison between Novartis and study sites for successful collaboration.
• Manage assigned study sites and ensure compliance with protocols.
• Conduct Site Initiation Visits and ongoing site training.

Conoscenze

Site management

Patient recruitment

Compliance

Collaboration

Risk mitigation

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

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, focusing on recruitment and quality, and identifies site needs and issues early. They serve as the primary point of contact both internally and externally for all sites.

About the Role

Key Responsibilities:

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

Minimum Requirements:

• Degree in Scientific disciplines.
• At least 1 year of experience as a CRA in a pharmaceutical company or CRO.
• Fluent in Italian and proficient in English (B2 level).
• Willingness to travel across Italy.

Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives. Join us and be part of a passionate team dedicated to making a difference. Learn more about our benefits and diversity initiatives. If this role isn’t suitable but you want to stay connected, join the Novartis Network or our talent community to receive updates on future opportunities.