Clinical Research Associate

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Research Associate to oversee clinical trials and ensure compliance with protocols. This role involves managing study sites, training personnel, and engaging with global teams to enhance patient recruitment and data quality. A degree in scientific disciplines and a minimum of one year of experience in a similar role is required.

Competenze

• At least 1-year experience as a CRA in pharma or CRO.
• Fluent in Italian with good knowledge of English (B2 level).
• Willingness to travel across Italy.

Mansioni

• Acting as the frontline liaison between Novartis and study sites.
• Conducting continuous site monitoring activities and ensuring compliance.
• Collaborating with project managers to optimize recruitment and data quality.

Conoscenze

Communication

Problem Solving

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 & quality), identifies site needs and issues early, and serves as the primary point of contact (internally & 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 ownership mindset.
• 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 trial aspects, and providing ongoing training as needed.
• Conducting continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH / GCP, regulations, and documentation standards.
• Identifying deficiencies in site processes, collaborating with sites on risk mitigation and process improvements.
• Promoting a culture of compliance and ethical integrity, ensuring 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 global and local teams.
• Performing Site Closeout activities per SOPs and regulations, ensuring proper follow-up and archiving.
• Collaborating with project managers and other stakeholders to optimize recruitment, site development, and data quality.
• Participating 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 pharma or CRO.
• Fluent in Italian with 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 towards our ambitions. Join us to be part of this mission and learn more about our benefits and diversity initiatives.