Clinical Research Associate I Milano

Clinical Research Associate I
Milano
Lombardia, Milano

All details of site management as prescribed in the project plans

- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks

- Negotiation of study budgets with potential investigators and cooperation with Labcorp Drug Development legal department with statements of agreements

- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs

- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems

**Requirements**:

- Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

- Excellent understanding of Serious Adverse Event (SAE) reporting

- Ability to resolve project-related problems and prioritize workload for self and team

- You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

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