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Study Coordinator (m/f) Darmstadt Germany,  


Posted on : 15 June 2017

Project Description

The department of Clinical Diagnostics is seeking a Study Coordinator (m/f) Tasks Design study documents, including protocols, consent forms, clinical site agreements, ethics committee applications, etc. Prepare clinical evaluation reports, develop partnerships with Clinical Research Organizations (CRO) Working closely with CRO and Study Principal Investigators to meet study tasks and deadlines Conduct sponsor oversight visits to assess sites/CRAs in adherence to study plans, protocols and GCP Monitor study logistics and performance Collaborate with Regulatory Affairs and Governmental Organizations to comply with new regulations and directives Facilitate study start with CRO including complete data capture system (eCRF) specifications and development Organize, host and prepare reports of study maintenance meetings Resolve study support issues in timely and proactive manner Work with confidential information and patient data Communicate progress status and reports to the project manager Perform data analysis and management Qualifications University degree (PhD or MD) or equivalent in Biology or Medicine 2+ years of experience in coordination of clinical studies Ideally, good knowledge of microbiology and understanding of IVD industry Ability to work in clinical settings High level of critical thinking, developed skills in problem-solving Excellent interpersonal and organizational skills, leadership abilities Entrepreneurial work style, strong attention to details Demonstrated ability to manage multiple tasks, resolve difficult situations with high degree of professionalism and good judgement Distinguished English and German skills in both oral and written communications Travelling (40%)

Locations

64297 Darmstadt Germany

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