CRA Medical Device

Pubblicato il 04/10/2011 alle ore 15:30

Chiltern is Europe’s largest privately owned full service (Phase I-IV) CRO, with over 1400 employees and 23 offices throughout Europe (both Eastern and Western), North and South America and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.
We currently have the following vacancies based at our offices in Milan, for the Resourcing Solutions Group
Clinical Research Associate
Ref AC 055
Job Primary Functions:
Clinical monitoring of specified sites to ensure quality and integrity of data, compliance with Chiltern International or Client’s SOPs, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.
Duties may include:
• Setting up clinical trials in Medical Devices area, surgical experience preferred.
• Carrying out monitoring activities
• Effective participation in regulatory and ethics committee submissions (in case)
• Safety monitoring
• Feasibility work
• Presenting to Investigators

Job Qualifications:
• A BSc or BA degree in a biomedical or related life science
• Previous CRA experience within clinical research and medical devices. Altough not required for the Medical Devoces area, preference will be given to CRAs with specific certification as per the DECREE dated 31 March 2008, “Definition of minimum requirements for contract research organizations (CROs) with respect to clinical trials on medicinal products”, with a minimum of 2 years
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
• Good oral and written communication, organizational skills and personal presentation.
• Fluent in English.
• Experience working in a team environment under time and resource pressures
• Understanding of the principles of ICH GCP and regulatory requirements
• Experience of the clinical research process and terminology
• Preferable experience using a clinical trial management system (CPMS)

We will give preference to candidate available Office based in Milan, applicants living in towns with good train and airport connections, will be considered for Home Based positions. If you would like the opportunity to work in a stimulating yet supportive Global CRO then please submit your CV to
Anna Corbani e: italian.info@chiltern.com dl: +39 (0)2 897894210
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