Clinical Research Associate

3 settimane fa


Lombardia, Italia MCR - Mediolanum Cardio Research s.r.l. A tempo pieno

Mediolanum Cardio Research è alla ricerca di un/a Clinical Research Associate (CRA) certificato/a di talento e motivato/a per unirsi al nostro team di ricerca clinica. Responsabilità Principali Il candidato ideale sarà responsabile della gestione e del monitoraggio delle attività degli studi clinici in conformità con i protocolli di ricerca, le Good Clinical Practice (GCP) e le normative vigenti. Le mansioni includono: Monitoraggio in loco, da remoto e centralizzato dei centri sperimentali (ospedali, cliniche). Verifica della conformità dei dati clinici (SDV - Source Data Verification) e gestione delle Query. Gestione dei Trial Master File (TMF) e Site Master File (SMF). Formazione del personale del centro sperimentale sul protocollo di studio e sulle procedure operative standard (SOP). Gestione delle visite di avvio (SIV), monitoraggio (IMV) e chiusura (COV). Comunicazione efficace con i Principal Investigators (PI) e i team di studio Assicurare la corretta gestione dei farmaci in studio e dei campioni biologici. Requisiti Essenziali Esperienza Comprovata: Almeno 2 anni di esperienza consolidata come CRA nel monitoraggio di studi clinici (Fase I-IV). Certificazione CRA: Essere in possesso della Certificazione/Idoneità alla funzione di CRA rilasciata ai sensi del D.M. 15 novembre 2011 (o normativa equivalente se lo studio è internazionale). Laurea: Laurea in discipline scientifiche (CTF, Farmacia, Biologia, Biotecnologie, Medicina, etc.). Conoscenza Normativa: Solida conoscenza delle Good Clinical Practice (GCP/ICH) e delle normative nazionali e internazionali pertinenti. Lingue: Ottima conoscenza della lingua inglese, scritta e parlata Soft Skills: Eccellenti capacità comunicative, organizzative e di problem-solving. Flessibilità e disponibilità a trasferte. Strumenti Informatici: Buona conoscenza dei sistemi EDC (Electronic Data Capture) e dei software di gestione della ricerca clinica (es. CTMS). STUDY COORDINATOR & DATA MANAGER (Ricerca)Cusano Milanino, Lombardy, Italy 1 week ago #J-18808-Ljbffr



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