Job ID359350 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code9742S1 Employee ClassAcad Prof and Admin About the Job Are you passionate about enhancing the way research is conducted to make a meaningful impact on people's lives? Leverage your clinical research experience in the Clinical and Translational Science Institute (CTSI) where you will be a part of a team accelerating discoveries toward better health by providing a comprehensive infrastructure of research services, training, grants, tools, and more. The Clinical Research Specialist plays a critical role in the Clinical Research Support Center (CRSC) by advising and educating investigators through the start-up process, from study concept to activation. This role will help investigators maneuver the clinical research start-up process at the University of Minnesota. The Specialist collaborates with investigators and engages experts to identify potential design and operational barriers and solutions. Work with Flexibility The Clinical Research Specialist position offers a highly-flexible remote work arrangement with limited required on-site presence. Essential Functions or Job Duties (50%) Study Planning & Protocol Development Develop and maintain strategic relationships with study teams, departments and other partners to ensure collaboration. Review study protocols for completeness, feasibility, compliance and optimal design for study success. Serve as the single point of contact for study teams; fostering navigational oversight to move study planning efforts forward. Lead efforts to review and understand the study protocol, goals and needs. Coordinate the preparation of study documents. Prepare study teams for successful ancillary reviews by leveraging support center experts and external collaborators. Lead the support center's feasibility review process. Manage and lead cross-functional teams including statistics, informatics, regulatory, and clinical partners. Navigate through complex issues independently utilizing extensive clinical research experience to identify creative solutions for issue resolution. Ensure compliance with all applicable regulatory standards and policies related to clinical research. (25%) Facilitate study activation Develop and drive comprehensive study start up timeline. Ensure study start up activities are completed to meet study timelines in collaboration with study teams and support center experts. Advise on strategies for meeting the goals, including plans to address potential timing risks/gaps. Liaise with Regulatory Affairs, Pre-award, Informatics, Clinical Partners and other team members to enable rapid clinical study start up. Identify issues before they become critical. Work through their resolution in collaboration with the study team and support center experts. Schedule, lead, and document regular project team meetings. Monitor project status. Ensures timely communication of study status to relevant stakeholders. (10%) Education and advisement Educate and advise researchers on the study management process. Serve as the content expert and provide customized and knowledgeable guidance to faculty and staff in the navigation of clinical research processes. Advise on the logistical implication of the resources required to conduct clinical research projects, including health data informatics, finance, biostatistics, research coordinators, biological sample management, participant recruitment, and various University committees that review and approve clinical research. Facilitate the connection between study teams and the appropriate experts. Assist departments in leveraging centrally available research resources in order to drive efficiencies in research administration and execution. Facilitate sharing of research insights, best practices and education opportunities. (10%) Initiatives and process improvement Identify fundamental issues or systemic gaps pertaining to study start up at t e University, provide in-depth analysis and recommendations on process improvements. Contribute to and/or lead initiatives aiming at modifying practices and procedures to improve efficiency and quality. Develop new opportunities for the support center and participate in new support center development activities including presentations. Create and implement clinical research tools and best practices, needed during the planning of feasible clinical research studies, to maximize the efficiency and conduct of research projects. (5%) Other Provide regular project level reporting for operational metrics, dashboards and other efforts. Qualifications All required qualifications must be documented on application materials. Required Qualifications BA/BS with at least 6 years of experience or advanced degree with 4 years of experience. Experience must include four years' experience with clinical and/or translational research. Preferred Qualifications Advanced degree in health, public health, or other biomedical disciplines. Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA), or equivalent (i.e., RAC). Experience working in a CTSI/CTSA. Experience working in managing multiple clinical studies with proven results in study activation. Experience with clinical research protocol development. Experience in developing a new program/service or expanding an existing program/service. Experience developing manuscripts, abstracts, posters or other presentations for professional or academic audiences. The employer reserves the right to change or assign other duties to this position. About the Department The University of Minnesota Clinical and Translational Science Institute (CTSI) mission is to accelerate and improve clinical and translational science research, education and improve health. CTSI provides consultation, training, support, and services to researchers and research teams across the translational continuum. CTSI is part of the national, NIH-funded Clinical Translational Science Award (CTSA) program/consortium that works together to improve the efficiency, quality, and impact of clinical and translational research and science. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.