Clinical Research Associate

Novartis Farmacéutica; Vercelli; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Research Associate (CRA) in Vercelli, Italy. The CRA will oversee clinical trials, ensuring adherence to protocols while enhancing site collaboration and compliance. Ideal candidates hold a scientific degree and have at least one year of experience, with a strong focus on recruiting participants and training site staff.

Competenze

• At least 1 year of experience as a CRA in a pharmaceutical company or CRO.
• Willingness to travel across Italy.

Mansioni

• Acting as the liaison between Novartis and study sites, managing site performance.
• Performing on-site and remote monitoring, ensuring compliance with protocols.
• Conducting Site Initiation Visits and providing ongoing training.

Conoscenze

Fluency in Italian

Good knowledge of English

Monitoring

Training

Compliance

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 (recruitment and quality), identifies site needs and issues early, and serves as the primary point of contact (internally and 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 mindset of ownership.
• Managing assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performing Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects, and providing ongoing training for amendments and new staff.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identifying deficiencies in site processes, working closely with sites on risk mitigation and process improvements.
• Promoting a culture of compliance and ethical integrity, safeguarding human subject protection and data reliability.
• 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, ensuring proper archiving and follow-up.
• Collaborating proactively with project managers, CRAs, MSLs, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
• Participating 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 Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives. We aim to become the most valued and trusted medicines company. Our people drive us daily. Join us and be part of this mission! Learn more in the Novartis Life Handbook. Novartis is committed to diversity and inclusion, building an outstanding, inclusive work environment.

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Clinical Research Associate • Vercelli, Italy