Clinical Research Associate

Novartis Farmacéutica; Asti; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a Clinical Research Associate to ensure the successful execution of clinical trials across Italy. In this role, you will manage site performance, conduct essential training, ensure compliance, and foster collaboration among study teams. If you have a degree in scientific disciplines and at least one year of CRA experience, this is an opportunity to contribute to innovative healthcare solutions.

Servizi

Diversity and inclusion initiatives

Career development opportunities

Competenze

• At least 1-year experience as a Clinical Research Associate (CRA).
• Fluency in Italian; good knowledge of English (B2).
• Willingness to travel across Italy.

Mansioni

• Manage assigned study sites and conduct phase I-IV protocols.
• Perform Site Initiation Visits and continuous monitoring activities.
• Collaborate with stakeholders to optimize recruitment and data quality.

Conoscenze

Site management

Monitoring

Compliance culture

Risk mitigation

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

The Clinical Research Associate ensures sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct, and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH / GCP, local regulations, and SOPs.

Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites.

About the Role

Your key responsibilities :

Your responsibilities include, but are not limited to :

• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectations on milestones and deliverables with true ownership mindset.
• Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Perform Site Initiation Visits, ensure site personnel are fully trained on all trial-related aspects, and provide ongoing training for amendments and new personnel as needed.
• Conduct continuous site monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identify deficiencies in site processes, monitor outside activities, collaborate closely with sites on risk mitigation and process improvements.
• Promote a compliance culture, ensuring adherence to high standards and ethical integrity, human subject protection, and reliable trial results.
• Establish strong partnerships with sites to increase patient density and minimize issues.
• Engage early with sites regarding patient inventory and flow, in collaboration with global and local study teams.
• Perform Site Closeout activities per SOPs and regulations, ensuring proper follow-up and archiving.
• Collaborate proactively with the SSO Clinical Project Manager, CRA Manager, and other stakeholders to optimize recruitment, site development, and data quality.
• Participate in audit and inspection readiness activities, ensuring corrective actions are implemented timely.
• Qualifications include a degree in Scientific disciplines, at least 1-year experience as a CRA, fluency in Italian, good knowledge of English (B2), and willingness to travel across Italy.

Why Novartis? Our purpose is to reimagine medicine to improve and extend lives. Join us to be part of this mission and learn more about our benefits, diversity, and inclusion initiatives.

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