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Lead CRA (m/f) Nr ref.: /JOBS.pl Our client is a medium-sized Clinical Research Organization operating in over 20 countries specializing in oncology, endocrinology, CNS and immunology. For further growth of the Polish team, we are currently hiring an experienced Lead CRA (m/f) office based in Warsaw in a permanent employment contract. In this challenging position you will be responsible for all site management activities including site monitoring, EC submissions and assistance with site contract and budget negotiations. Responsibilities: Travel to monitor sites inside and occasionally outside of Poland Assume line management responsibility for a group of CRAs Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries Conduct any kind of on-site monitoring visits (pre-study, initiation, routine monitoring, site closure) Review of and/or input to the study protocol, CRF and validation tools Preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents Preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities Assisting with Investigator and Institution contracts, negotiating budgets and arranging site payments Query management in cooperation with the Clinical Data Management Team Assisting sites and the study team in managing contacts to external service providers such as central laboratories Participation in feasibility studies and Investigator selection Responsibility for Site Management Requirements: University degree in sciences or related fields; nursing degree or comparable education Experience with submissions of clinical studies to CA and ECs in Poland Extensive know how and understanding of GCP and the environment of clinical studies Know-how and experience about conduct of medical device studies in Poland is advantageous Ability and willingness to build up a clinical monitoring group from scratch Self-starting and ambitious attitude to actively drive things forward Fluency in Polish and English both spoken and written (additional German is a plus) Work experience > 5 years preferably in international projects Experience in an international CRO is beneficial (First) experience as Lead CRA is an advantage Friendly, open, motivated and optimistic personality Awareness and willingness regarding remote line management Solid IT - know how of standard PC applications (MS Office, eCRF, TMF) The offer: Our client offers an exciting and challenging work environment for team-oriented clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching pharmaceuticals that improve health and quality of life. Interested? Please send your application to . We are looking forward to getting to know you. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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