Become part of something meaningful. Work with over 2,000 specialists from over 100 professions and enable people with a spinal cord injury to lead a self-determined life.These are your tasksProvide high quality regulatory affairs-related services for investigators in the field of patient-oriented research with a risk-based approach (e.g. review of study protocols and other essential study documents)Promote the implementation of the ICH Good Clinical Practice (ICH-GCP) guidelinesBe subject matter expert for regulatory affairs related topics in the context of clinical trials and research projectsBe responsible for the quality management system of the CTU, i.e. development, implementation and maintenance of study related processes, incl. SOPs, forms and other related documentsSupport clinical researchers with the registration of studies in official national and international registriesSubmit study documents for selected studies' approval by ethics committeesSupport study teams in the context of audits and inspections by ethics committees or regulatory authoritiesTeach on national and international clinical research regulations (e.g. Human Research Act (HFG); ICH-GCP guidelines)What makes you stand outMaster in health or natural sciences; PhD would be an advantageExcellent knowledge of and experience in working with national and international clinical research regulations (e.g. HFG, ICH-GCP)Profound knowledge and experience of processes in patient-oriented research; including trials with medical devices and medicinal productsExperience with audits and inspections by ethics committees or regulatory authorities is an advantageGood knowledge of rehabilitation medicine and spinal cord injury/disease is an advantageExcellent German (business fluent) and good English language skills; both spoken and writtenSelf-managed way of working, strong customer orientation, able to work in a team, excellent communication skillsWhat you can expectAbout Us Swiss Paraplegic Research (SPF) is part of the Swiss Paraplegic Group. The mission of SPF is sustainably improving the situation of people with spinal cord injury (SCI) through interdisciplinary, clinical and Community-based research on a national and international level. Specific areas of its comprehensive research include functioning, mobility, social integration, equality of opportunity, self-determination, quality of life, health services provision as well as epidemiology and statistical methods. SPF is an university research institution recognized and promoted by the Swiss federal government and the cantons and an active link to academic and industrial research and development at the national and international levels.
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