Clinical Research Associate

Novartis Farmacéutica; Alessandria; In loco; EUR 30.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading company in pharmaceuticals seeks a Clinical Research Associate to manage clinical trials and ensure compliance in Italy. Key responsibilities include site management, training personnel, and enhancing patient enrollment efforts. The ideal candidate will hold a degree in scientific disciplines and possess a strong commitment to compliance and collaboration.

Competenze

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

Mansioni

• Liaison between Novartis and study sites, ensuring collaboration and compliance.
• Conduct Site Initiation Visits and continuous monitoring.
• Engage with sites on patient inventory and flow.

Conoscenze

Site performance management

Compliance with ICH/GCP

Training and support

Risk mitigation

Fluent in Italian

English (B2 level)

Formazione

Degree in Scientific disciplines

Descrizione del lavoro

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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