Clinical Trial Start Up Specialist Area No-Profit

5 giorni fa


Bardi, Italia Humanitas A tempo pieno

La figura si occupa della gestione delle pratiche etico amministrative di studi clinici no-profit.
L'attività prevede il coordinamento delle varie funzioni interne e di consulenti esterni preposti al controllo e verifica della documentazione necessaria per l'attivazione di studi clinici no-profit (avvocato, amministrazione, personale medico, farmacia, comitato etico).
In particolare l'attività prevede di:
- supportare i medici/ricercatori nel disegno di protocolli, in termini di metodologia e obiettivi;
- supportare i medici/ricercatori nella stesura di tutta la documentazione necessaria per la valutazione del CE;
- gestire il percorso di istruttoria degli studi (analisi privacy, analisi normativa, analisi di fattibilità interna, copertura assicurativa, etc);
- effettuare una analisi di fattibilità (normativa, scientifica e costi) e finalizzare la documentazione per il CE di studi con promotore esterno;
- finalizzare il budget di studi con supporto economico esterno e le convenzioni con parti terze (supporter/CRO/promotore);
- supportare il Grant Office per la presentazione dei progetti a bandi di ricerca nazionale ed internazionale.
Profilo:
Laureato in discipline scientifiche quali: biologia, chimica o biotecnologie con pregressa esperienza lavorativa nell'ambito della ricerca clinica
Ottima conoscenza della lingua inglese, forte interesse per il settore sanitario e la ricerca clinica, capacità di relazionarsi con le diverse funzioni aziendali, mediche e non; buona capacità di lavorare in team; organizzazione, precisione, problem solving completano il profilo.



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