Clinical Research Operations Coordinator

2 settimane fa

Roma, Italia SIAARTIMandragora srl A tempo pieno

SIAARTI (Società Italiana di Anestesia, Analgesia, Rianimazione e Terapia Intensiva) è alla ricerca di un/una Clinical Research Operations Coordinator da inserire in collaborazione per il supporto operativo a studi clinici multicentrici non profit condotti su tutto il territorio nazionale.

**Responsabilità principali**:

- Supportare il Principal Investigator nella stesura e revisione dei documenti CORE (protocollo, sinossi, informativa, consenso informato, ecc.);
- Gestire gli iter autorizzativi e amministrativi degli studi multicentrici, inclusa la corrispondenza con Comitati Etici e Direzioni Generali dei centri satellite;
- Coordinare la contrattualistica con i centri partecipanti, in collaborazione con l’Ufficio Legale SIAARTI per gli aspetti giuridici;
- Predisporre e strutturare le CRF elettroniche tramite piattaforma REDCap, inclusa la gestione del data cleaning;
- Supervisionare l’avanzamento dei progetti clinici assegnati.

**Requisiti richiesti**:

- Esperienza documentata di almeno 2 anni nella gestione autonoma di studi clinici, preferibilmente multicentrici (almeno 20 centri), e in contesti non aderenti al parere unico (studi non farmacologici);
- Ottima conoscenza degli iter autorizzativi e operativi previsti per gli studi non profit;
- Conoscenza della normativa europea e italiana sulla privacy e sulla gestione dei dati clinici, con particolare riferimento al GDPR;
- Flessibilità operativa, attitudine al problem solving e capacità di lavorare in team multidisciplinari;
- Preferibile formazione specifica sulla gestione di clinical trial, anche tramite corsi dedicati;
- Esperienza nell’uso di REDCap o piattaforme equivalenti per la costruzione e gestione di CRF (inclusi studi RCT);
- Laurea in discipline scientifiche (es. Biomedicina, Farmacia, Scienze Infermieristiche, Scienze Statistiche o affini);
- Ottima conoscenza della lingua italiana e buona padronanza dell’inglese scientifico.

**Dettagli contrattuali**:

- Contratto di collaborazione con durata iniziale di 12 mesi (rinnovabile);
- Impegno su 3-4 studi multicentrici in corso e in fase di attivazione;
- Compenso annuo lordo a partire da 14.000 €, per un impegno medio di 20 ore settimanali. È prevista la possibilità di incremento proporzionale in base al numero di progetti assegnati e all’esperienza maturata nella gestione autonoma di studi clinici.

**Sede**:
L’attività si svolgerà a Roma, presso la sede SIAARTI.

Contratto di lavoro: Collaborazione
Durata contratto: 12 mesi

Retribuzione: a partire da €14.000,00 all'anno

Esperienza:

- Clinical research office: 1 anno (Obbligatorio)

Lingua:

- Inglese (Obbligatorio)

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