Clinical Research Associate

6 giorni fa

Milano, Lombardia, Italia MCR - Mediolanum Cardio Research s.r.l. A tempo pieno 30.000 € - 60.000 € all'ano

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).

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