A Senior CRA job position has opened up at an international contract research organisation providing drug discovery, lifecycle management and laboratory services. With offices in over 45 countries and approximately 13,000 professionals, this company provide innovative ideas behind multiple sectors. This particular position will be based in Milan, Italy.
The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and company Standard Operating Procedures. Conducts site visits to assess protocol and regulatory compliance and manages required documentation; Responsible for ensuring that data will pass international quality assurance audits. Represents the company in the global medical research community and develops and maintains collaborative relationships with investigational sites. Required to travel 50% on average.
Skills and Requirements:
- University degree in a science related field
- Qualified as per the Ministerial Decree dated 15/11/2011
- At least 1.5 years' monitoring experience in clinical development phase II-IV
- Understanding of ICH-GCP, EU and FDA requirements
- Fluency in English and in Italian
- Valid Driver's License where applicable
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Good organizational and time management skills
- Ability to work in a team or independently as required
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
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 Theodora Savlovschi-Wicks on +44 203 7520 314 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.