Clinical Trial Monitor

4 settimane fa


Milano, Italia Istituto Auxologico Italiano A tempo pieno

Auxologico è alla ricerca di un/una Clinical Trial Monitor da inserire all'interno del Laboratorio di Cardiologia per il monitoraggio di uno studio di prevenzione primaria cardiovascolare nella popolazione italiana promosso da Rete Cardiologica e supportato dal Ministero della Salute.

**Nello specifico la risorsa si occuperà di**:
monitoraggio e verifica della conformità dei dati (verifica dei consensi informati, controllo dei dati sorgente, emissione di query, controllo di AE/SAE, controllo terapie, verifica delle deviazioni al protocollo, etc) riportando i risultati dello studio al PI.
assicurare il rispetto di tutti gli standard di ricerca stabiliti dalle ICH-GCP, e normative vigenti anche in materia di privacy (GDPR);
sviluppare adeguati piani di monitoraggio basati sul rischio in base alla complessità dello studio;
verificare la completezza e la correttezza del TMF.

**Requisiti**:
Laurea in materie scientifiche;
Esperienza maturata nel ruolo per il monitoraggio e la gestione dei dati di almeno 5 anni;
Ottima conoscenza delle ICH-GCP, delle direttive AIFA e Ministeriali nell’ambito degli studi clinici profit e no-profit e delle normative vigenti in tema di protezione dei dati personali (GDPR). Saranno particolarmente apprezzate le conoscenze in ambito regolatorio europeo e internazionale.
competenze nella preparazione e revisione dei documenti di studio per la sottomissione alle autorità competenti (CE, AIFA, Ministero) nell’ambito di studi nazionali e internazionali e loro archiviazione (ISF e TMF);
conoscenze e utilizzo dei principali software, database, portali, piattaforme e sistemi di gestione dati per gli studi clinici (IWRS/IVRS, IRT, eCRF, etc) e capacità di disegno e definizione delle variabili in CRF;
Competenza e utilizzo di tutte le applicazioni Microsoft Office (Word, Excel, Outlook, PowerPoint);
Buona conoscenza della lingua inglese

**Caratteristiche personali**:
Ottime capacità di comunicare in modo efficace con i vari interlocutori;
Ottime capacità organizzative;
Buona attitudine al problem solving;
Proattività e orientamento al risultato.
Ottima attitudine al team-working.



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