Clinical Research Associate

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Research Associate (CRA) to oversee clinical trials' execution and ensure compliance with regulations. The role involves managing study sites, monitoring activities, and maintaining strong partnerships to enhance recruitment and data quality. Ideal candidates hold a scientific degree and have CRA experience.

Competenze

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

Mansioni

• Manage assigned study sites, ensuring compliance with protocol and regulations.
• Conduct training for site personnel and continuous site monitoring.
• Act as the frontline liaison between Novartis and study sites.

Conoscenze

Communication

Attention to Detail

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 actively manages site performance (recruitment and quality), identifying site needs and issues early. They serve as the primary point of contact (internal and external) 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, train site personnel on trial-related aspects, and provide ongoing training for amendments and new staff.
• 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 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 archiving and follow-up.
• Collaborate proactively with project managers, MSLs, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
• Participate in audits and inspections, ensuring corrective actions are implemented timely.

Minimum Qualifications:

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

Why Join Novartis?

Our purpose is to reimagine medicine to improve and extend lives. We value our people, who drive us daily towards our ambitions. Join us to be part of this mission!

We are committed to diversity and inclusion, building an inclusive work environment that reflects the communities we serve.

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