Summary

Monitora i dati dei pazienti e le informazioni relative allo studio relative ai siti di studio clinico e alla partecipazione agli studi clinici.. Assicura che il ricercatore aderisca ai protocolli di ricerca, ai requisiti normativi e alle buone pratiche cliniche e fornisce input nel piano di convalida dei dati. Fornisce un monitoraggio tempestivo e accurato dei dati dei pazienti e delle informazioni relative allo studio da documenti di origine, registri di ricerca e visite in loco, ove applicabile. Può monitorare i siti di studio e la selezione delle strutture di audit.

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 expectation on milestone and deliverables with true ownership mindset.
• Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate.
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements.
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team.
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
• Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality.
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.

• 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 the whole country (Italy).