Senior Clinical Research Associate (SIA) based in Moscow, Smolensk or
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PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.PPD was named Best Technological Development in Clinical Trials at the 2012 Scrip Awards and Clinical Team of the Year at the PharmaTimes 2012 Awards.Today we're giving you the opportunity to become part of our Site Intelligence and Activation team in PPD Russia on the position of: Clinical Research Associate (SIA) - based in Moscow, Smolensk or St. PetersburgThe role will facilitate effective communication between investigational sites and the PPD project team. Primary responsibilities will include identifying investigators, site evaluation, producing pre study visit reports and collection of essential documents. Other responsibilities may include the support of the Site Intelligence and Activation team in activities related to the Ethics Committees submission and the preparation of Regulatory Compliance Review packages. You will play a key part in coordinating the rapid start up phase of studies and as such will spend a significant amount of working time on site. You must possess excellent communication and interpersonal skills to enable you to develop key relations with site staff. In addition, you will need strong attention to detail with the ability to work independently. You will be authorised to perform PSVs and be able to demonstrate effective evaluation visits. QualificationsIn order to be successful on this role you should have:• Several years of monitoring experience • In-depth knowledge of ICH-GCP, EU and FDA requirements• Excellent English • Willingness & ability to travel• Capability to work in a team• Flexibility and ability to work on multiple projects and to support tasks such as feasibilities, site contracts and budgets, submission documentation and contribute to regulatory country intelligence as required• Experience of starting up clinical studies or contributing to start up tasks.HOW TO APPLY: Please submit your CV in English. Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience. Suitable candidates will be contacted accordingly.