Clinical Monitor

7 mesi fa


Bologna, Italia Ecol Studio TPU srl A tempo pieno

Ecol Studio, per la propria divisione Yghea, contract research organization, è alla ricerca di un Clinical Monitor. La risorsa, inserita all'interno di un team e riportando al Project Manager, si occuperà di:

- Eseguire le attività relative al monitoraggio (on site e/o centralizzato) pertinenti la selezione, l'inizio, il monitoraggio in corso di studio e la chiusura dello studio in accordo ai principi contenuti nelle ICH-GCP e alle normative applicabili, alle procedure operative standard e standard di qualità forniti, ai piani di monitoraggio (TMP) e di Source Data Verification definiti dal Project Manager o dal Promotore;
- Sorvegliare le attività di studio presso un centro sperimentale, aggiornare tempestivamente il Project Manager o il Promotore in merito alle criticità evidenziate e assistere gli sperimentatori nella soluzione di tali criticità secondo le azioni correttive discusse con il Project Manager o il Promotore;
- Redigere i rapporti di visita e dei rilevanti contatti telefonici secondo modulistiche e istruzioni ricevute dal Project Manager o dal Promotore;
- Gestire e controllare il Trial Master File (TMF).
Requisiti:

- Laurea Magistrale in discipline Scientifiche (Farmacia, CTF, Biologia, Chimica, ecc.);
- Preferibile esperienza nel ruolo o comunque possesso della formazione teorica, secondo quanto previsto dal DM 15 novembre 2011, per lo svolgimento delle attività tipiche della figura di Clinical Monitor;
- Buona conoscenza della lingua inglese;
- Ottime capacità organizzative e di gestione del tempo; spirito di squadra.
Offriamo:

- Inquadramento commisurato all'esperienza e competenze acquisite;
- Percorso di acquisizione di competenze specializzate;
- Sviluppo professionale continuo;
- Inserimento in un contesto giovane, dinamico e modernamente strutturato.

Il presente annuncio è rivolto ad entrambi i sessi, ai sensi delle leggi 903/77 e 125/91, e a persone di tutte le età e tutte le nazionalità, ai sensi dei decreti legislativi 215/03 e 216/03



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