CLINICAL RESEARCH ASSOCIATE

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.
Essential requirements.
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).