Clinical Research Associate Nr ref.: /JOBS.pl Chiltern is Europe's largest privately owned Clinical Research Organisation, with offices throughout Europe, both Eastern and Western, North and South America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones. Due to our continuing success and expansion, we are currently looking for experienced (Senior) Clinical Research Associate(s) to work with our team in Leuven / Louvain! The CRA is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The work will involve Clinical Monitoring activities for designated projects and to monitor specified sites to ensure quality and integrity of data, compliance with Chiltern International or Sponsor's SOPs, ICH GCP, and regulatory requirements, ensuring study completion on time and within budget. Duties & Responsibilities Setting up clinical trials in a oncology of therapeutic area To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs Feasibility work. To provide appropriate support for the preparation, submission/notification of local regulatory approval if required for local country requirements Requirements • A BSc or BA degree in a biomedical or related life science, or nursing qualification • Previous CRA experience within clinical research (minimum 2 years). Oncology experience is preferred. • Good clinical knowledge with an understanding of medical terminology • An understanding of the basics of physiology and pharmacology • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications • Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English, Dutch and French • 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) For more extensive information about Chiltern, please visit our web site at For a confidential discussion about this opportunity, please telephone Baudi Heidanus on (0)6 . Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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