Clinical Data Manager
4 mesi 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.);
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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