Clinical Data Manager
6 giorni fa
L'IRCCS Ospedale San Raffaele, struttura clinica-scientifica-universitaria di rilievo internazionale e di alta specializzazione per diverse importanti patologie, sta ricercando un Clinical Data Manager / Clinical Study Coordinator da inserire nella propria Unità Operativa di Chirurgia Vascolare.
Attività principali: Sottomissione di studi clinici spontanei e sponsorizzati al Clinical Trial Center (CTC) e al Comitato Etico (CE); Supporto allo staff clinico per la stesura di protocolli spontanei; Inserimento dati clinici in database elettronici e Case Report Form (CRF); Report di eventi avversi e eventi avversi seri (SAE); Collaborazione con il personale delle Contract Research Organization (CRO) per pratiche relative agli studi clinici (sottomissione studi sponsorizzati, visite di inizio studio – SIV, visite di monitoraggio etc.
); Organizzazione visite di arruolamento e di follow-up dei pazienti arruolati.
Cosa non può mancare: Laurea in discipline scientifiche-biologiche e/o frequentazione di corsi postgraduate o master relativi alla ricerca clinica; Conoscenza dei concetti base della ricerca clinica (tipi di studi, ruolo delle figure coinvolte – Investigator, PI, CE, CRO etc.
); Conoscenza di base della normativa e dei processi che regolano le sperimentazioni cliniche (Good Clinical Practice, consenso informato, sottomissione al CE, notifiche obbligatorie etc.
); Familiarità con pacchetto Office e programmi di inserimento e gestione dei dati (Excel etc.
); Conoscenza di base della lingua inglese e familiarità nella comunicazione scritta (email) in inglese; Puntualità e rispetto delle scadenze; Precisione e gestione autonoma dei compiti assegnati.
Dettagli lavorativi: Tipologia contrattuale: full-time; Durata: indeterminato; Sede: IRCCS Ospedale San Raffaele, via Olgettina, n. 60 - Milano.
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