Our client is one of the top 10 CROs in the world, with more than 13,000 employees in 60 countries. They are recruiting for a CRA II to work in a home-based role in Milan, Italy.
CRAs manage all aspects of study site monitoring according to the company's SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:
- All aspects 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, organisation of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with 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 company or client data management systems
- 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 prioritise workload for self and team
- You must have previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kellie-Marie Saul on +44 203 823 4366 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.