Job ID359182 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P3 Employee ClassCivil Service About the Job The Department of Neurology at the University of Minnesota is seeking a Project Manager to support the N. Bud Grossman Center for Memory Research and Care. N. Bud Grossman Center for Memory Research and Care conducts translational and clinical research in the areas of neurodegenerative disorders (e.g. Alzheimer's disease (AD), vascular dementia, Frontotemporal dementia (FTD), Lewy Body Dementia (LBD), mild cognitive impairment, Prion disease, Huntington's disease, Parkinson's disease related dementia (PDD), Traumatic brain injury (TBI) related cognitive impairment, and Chronic Traumatic Encephalopathy). We have a mix of federally funded and philanthropy supported studies. This position will coordinate and manage multi-faceted studies across the N. Bud Grossman Center from initiation to closure coordinating the research team through milestones. This position will also develop REDCap databases for the storage and analysis of data for a variety of studies (including e-consent databases), and prepare initial and ongoing submissions of IRB regulatory paperwork. The University has a flexible policy regarding working remotely. However, this is not a fully remote position; many studies have fully electronic regulatory files, but some older studies still have paper files. Some meetings may be required to be in person. The amount of time spent remote vs. in person will vary, and will be determined by your duties in a given week. You will be provided with a UMN laptop to enable you to carry out remote work securely. We are seeking highly motivated candidates with strong project management and organizational skills and who have a high level of professionalism. We will provide training for those unfamiliar with the various platforms involved in regulatory work at the University of Minnesota. Job Duties/Responsibilities: 1) Project Management and Communication (51%) - Ensure the overall project schedule and planning align - Development of project workflows and timelines given proposal priorities and milestones - Keep team on track to reach and achieve milestones on time - Support the planning, logistics, and facilitate project meetings, conference calls, advisory council meetings and stakeholder meetings - Establish and maintain partnerships with key stakeholders - Develop and implement comprehensive timelines, project plans, and identify resources to manage and meet deadlines 2) Regulatory Processes for Opening New Projects (30%) - Create regulatory files for new studies; - Complete IRB and other required review committee applications on assigned protocols; - Draft study-related informed consent documents according to Sponsor and University requirements; - Provide guidance and direction to team in order to ensure regulatory compliance - Draft study-related correspondence, including preparing FDA submissions, for study PI; - Create and maintain all required documents for assigned regulatory binders; - Assist PIs and Research Manager with coordination of all activities relative to initiation of assigned projects; - Communicate with all University and hospital departments to collect needed information for initiating new projects and opening new study research accounts. - Assist PIs, project managers, and coordinators in preparation for audits/monitoring visits 2) Regulatory Processes for Continued Management of Active Projects (19%) - Facilitate continuing review compliance for IRB and annual reports for FDA and Sponsors - Process study amendments, including protocol and consent changes, for PIs and study coordinators -Track and communicate changes to protocol specific requirements - Prepare for and assist with internal and external monitoring visits - Archive study materials when appropriate - Update REDCap e-consent, Florence eBinders, OnCore as appropriate Qualifications Requ red Qualifications: - BA/BS with at least 4 years of experience or a combination of education and work experience to equal 8 years - Years of experience to include a minimum of two (2) years experience in clinical research setting - Demonstrated ability to initiate and process multiple projects simultaneously - Experience with Office Suite, Google Apps, and web-based systems for tracking activities, calendaring, and retrieving/updating information. - Possess excellent communication skills; verbal and written. -Demonstrated ability to provide excellent customer service to internal and external clients Preferred Qualifications: - Knowledge of medical terminology -Working experience in the preparation of IRB applications - Working knowledge of regulations governing research activities (such as GCPs, FDA regulations and ICH guidelines) - Professional experience on a clinical research project team - Experience in clinical research at an academic health center - Experience with investigational drug trials (e.g., INDs) - Certification as a clinical research professional with SoCRA or ACRP or willingness to obtain certification at time of eligibility. - Experience with REDCap, OnCore, Asana, and/or Florence 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 contribution Public Service Loan Forgiveness (PSLF) Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost with free or reduced rates in the Twin Cities metro area Please visit the for more information regarding benefits. How To Apply Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail [email protected] or call (612) 624-UOHR (8647). Diversity 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... 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.