Quality Assurance Sperimentazioni e Ricerca

1 mese fa


Milano, Lombardia, Italia Humanitas A tempo pieno

In funzione del potenziamento delle attività di ricerca e sperimentazione dell'Ospedale Humanitas San Pio X, siamo alla ricerca di una risorsa che supporti l'Ufficio Sperimentazioni Cliniche di Humanitas nella gestione e controllo dei processi di qualità per quanto riguarda gli studi clinici e la relativa documentazione.

In particolare avrà la responsabilità di:

  • Identificare i processi, redigere le necessarie procedure operative standard (SOP), e la modulistica relativa, per descrivere le attività correlate alle sperimentazioni cliniche, mantenendole aggiornate e coerenti con gli assetti organizzativi e procedurali, le ICH Good Clinical Practice (GCP) e la normativa applicabile.
  • Provvedere ad un'appropriata formazione sulle SOPs e sulla normativa di riferimento del personale coinvolto nelle sperimentazioni cliniche.
  • Fornire supporto in caso di audit da parte degli Sponsor e ispezioni delle Autorità Competenti sulle sperimentazioni condotte presso Humanitas.

La risorsa ideale conosce la normativa relativa alle sperimentazioni cliniche e le ICH GCP.

Nel caso di studi interventistici con farmaci possiede i requisiti richiesti dal Decreto Ministeriale del 15/11/2011 sui requisiti minimi delle CRO (requisito non mandatorio).

Completano il profilo doti organizzative e gestionali, propensione al lavoro in team, flessibilità e capacità di relazionarsi a diversi livelli aziendali.

La ricerca è rivolta ad entrambi i sessi ai sensi della legge L.903/77.


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