<p>The Clinical Research Advisor is a newly created position within the Clinical and Translational Science Institute (CTSI) at the University of Minnesota. The Clinical Research Advisor will be affiliated at the Medical School Administrative Center level, with responsibilities for assigned departments. The Clinical Research Advisor will serve as the primary liaison between the University of Minnesota Medical School assigned departments, MHealth clinical facilities, and CTSI. The position is expected to improve integration and collaboration between CTSI resources and investigators, while assisting their assigned departments in research administration and oversight. The Clinical Research Advisor will:</p><ul><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">10% - Ensure the assigned departments have the appropriate visibility/reporting on their research portfolio to facilitate resource planning, oversee studies and research processes, and to inform strategic planning. Oversee that departments are using OnCore/TASCS clinical trial management system and integrated reports from other related systems (IRB/SPA).</li><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">20% - Assist departments and faculty in managing and coordinating their research support workforce, including: training staff directly, identifying training opportunities, onboarding, capacity management and staff utilization, recruiting and hiring and managing employee leaves and transitions.</li><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">20% - Educate researchers on the study management process from start-up to closeout. Work with research coordinators and finance teams to optimize research processes and procedures in all aspects of study management so that research occurs in a compliant, rapid and efficient manner within a patient-centric framework.</li><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">20% - Quality Assurance: Work with assigned departments to ensure research studies in comply with regulatory and university requirements with special emphasis on studies without sponsor oversight. Support research practices and ensure appropriate monitoring of the research to protect the rights and welfare of all research participants.</li><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">20% - Assist assigned departments in leveraging centrally available CTSI research resources in order to drive efficiencies in research administration and execution. Facilitate sharing of research insights, best practices and education opportunities. This includes providing training opportunities to ensure optimization of the available tools.</li><li style="margin: 0.25pt 0in 0.0001pt; text-indent: 0.5pt;">10% - Work with assigned departments to identify and align on specific activities and goals to support the needs specific to the department research portfolio and researchers.</li></ul>
<p>Required Qualifications</p><ul><li>BA/BS with at least 8 years of experience or an advanced degree with 6 years of experience.</li><li>Ability to understand and communicate clinical research protocol information.</li><li>Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Regulatory Affairs Certification (RAC) or qualified to sit for certification and must be obtained within 1 year.</li><li>Extensive experience with clinical and/or translational research processes.</li><li>Knowledge of clinical research regulations and guidance, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (including but not limited to 21 CFR 312 and 812), ICH GCP, and HIPAA regulations.</li><li>Prior oversight of a small department or cross-disciplinary team</li></ul><p>Preferred Qualifications</p><ul><li>Experience in an academic medical center.</li><li>Previous project management experience. Excellent organizational skills.</li><li>Experience in leading and facilitating operational and cultural change in an organization</li><li>Strong written and oral communication skills.</li><li>Ability to work independently and collaboratively as part of a team.</li></ul>
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.