<p><strong>Duties/Responsibilities:</strong><br />The MnDRIVE Deep Brain Stimulation Research Core in the Department of Neurology seeks a Regulatory Specialist to provide regulatory support for new and ongoing clinical trials and research projects. <br /><br />Duties include but are not limited to providing:<br />1) Regulatory Processes for Opening New Projects (40%)<br /> -Create regulatory files for new studies;<br /> -Completes IRB and other required review committee applications on assigned protocols;<br /> -Drafts study-related subject informed consent form documents according to Sponsor and University requirements;<br /> -Provide guidance and direction to team in order to ensure regulatory compliance<br /> -Drafts study-related correspondence, including preparing FDA submissions, for study PI;<br /> -Creates and maintains all required documents for assigned regulatory binders;<br /> -Assists PIs, Core Manager and Project Manager with coordination of all activities relative to initiation of assigned projects;<br /> -Communicate with all University and hospital departments to collect needed information for initiating new projects and opening new study research accounts.<br /> -Assist PIs and Core and Project Managers in preparation for audits/monitoring visits<br /><br />2) Regulatory Processes for Continued Management of Active Projects (50%)<br /> -Faciliates continuing review compliance for IRB and annual reports for FDA and Sponsors<br /> -Processes study amendments, including protocol and consent changes, for PIs and study coordinators<br /> -Tracks and communicates changes to protocol-specific requirements<br /> -Prepares for and assists with internal and external monitoring visits<br /> -Archives study materials when appropriate<br /><br />3) Process Improvement (10%)<br /> -Makes recommendation for improvements to processes and initiate process improvement<br /> -Communicate in a clear and professional manner changes to processes<br /> -Assists in the development of SOPs for regulatory processes<br /> -Enters information into study management databases (e.g., OnCORE)<br /> -Monitors trends in regulatory/protocol processes and makes recommendations for improvement<br /> -Assists with monitoring according to Core and Department procedures<br /> -Tracks and assists with implementing changes in regulatory processes as needed<br /> -Participates in training of new staff as needed<br /> -Fulfills special requests for data management and other duties as needed</p><p> </p>
<p><strong>All required qualifications must be documented on application materials. </strong></p><p><strong>Required Qualifications:</strong><br />-BA/BS plus at least 4 years of experience or advanced degree plus 2 years of experience or a combination of related education and work experience to equal eight years<br />-Minimum of one (1) year experience in clinical research setting <br />-Working experience in the preparation of IRB applications <br />-Working knowledge of regulations governing research activities (such as GCPs, FDA regulations and ICH guidelines)<br />-Demonstrated ability to initiate and process multiple projects simultaneously<br />-Experience with Office Suite, Google Apps, and web-based systems for tracking activities, calendaring, and retrieving/updating information.<br />-Possess excellent communication skills; verbal and written.<br />-Demonstrated ability to provide excellent customer service to internal and external clients </p><p><strong>Preferred Qualifications:</strong><br />-Professional experience on a clinical research project team<br />-Experience in an academic health center<br />-Experience with medical devices (e.g., IDEs)<br />-Knowledge of medical terminology<br />-Certification as a clinical research professional with SoCRA or ACRP or willlingness to obtain certification at time of eligibility. </p><p> </p>
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.