Worldwide Clinical Trials

Clinical Research Associate II or Senior CRA - Italy

26 Feb 2018
03 Jan 2019

This permanent Clinical Research Associate II or Senior CRA is responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

This position can be home-based or office based from Rome.

Successful candidates will have the following:

• Minimum of 2 years of previous independent field monitoring experience (required)
• Four-year life science degree preferred (or advanced degree)
• Thorough understanding of clinical research principles and process
• Thorough understanding of EU Directives and regulations, ICH Guidelines and local regulatory requirements
• Proficiency with IxRS, EDC systems
• Basic knowledge of three to five therapeutic areas, sufficient to function as a CRA or have an in-depth knowledge of two to three therapeutic areas
• Valid current passport required
• Driving license required
• Fluent in the local languages of the countries under responsibility and proficient in both spoken and written English
• Strong experience in CNS/Cardiology/IMID a plus