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Regulatory Specialist 1
University of Minnesota, Twin Cities
This position is responsible for providing regulatory guidance and regulatory management of clinical research protocol documents and activity from initial submission through study closure for clinical trials conducted in the Clinical Trials Office (CTO) of the Masonic Cancer Center. Incumbent at this level is an experienced professional competent to work at a high technical level.
Responsibilities/duties: Regulatory Management of Clinical Studies (100%)
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All required qualifications must be documented on application materials. Required Qualifications: -Bachelor’s degree in health, public health, biomedical disciplines plus two years of work experience in research; or a combination of related education and work experience in research totaling six years. -Experience with regulations governing research activity (such as GCPs, FDA regulations and ICH guidelines). -Experience developing and working complicated project schedules. -Computer proficiency in a PC environment including Microsoft Office products. Preferred Qualifications: -Clinical Research Coordination certification. -Experience in oncology clinical research setting. -Previous professional experience on a clinical research project team or similar environment. -Experience writing and adapting patient consent forms for research studies. -Experience in an academic medicine setting. |
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