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Job ID358412 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P1 Employee ClassCivil Service About the Job Job Duties/Responsibilities: Duties include but are not limited to providing: 1) Clinical Research Coordination (40%): - Contribute to study start-up activities, including site initiation visits, OnCore set-up, document template and flow sheet creation, study staff training and clinical in-services. - Patient recruitment, screening, consent, enrollment, and necessary registrations. - Perform study testing. - Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers. - Perform protocol procedures and specimen collection and processing. - Coordinate/conduct quality control checks as related to study conduct. - Maintenance of subject research charts. - Coordinate study close-out activities. 2) Regulatory Compliance and Support (20%): - Responsible for the interpretation of, application of, and compliance with federal regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as they relate to assigned research protocols. -Under supervision of MnDRIVE and Psychiatry Regulatory Specialist, creates regulatory files for new studies; -Completes IRB and other required review committee applications on assigned protocols; -Drafts study-related subject informed consent form documents according to Sponsor and University requirements; -Drafts study-related correspondence, including preparing FDA submissions, for study PI; -Under supervision of MnDRIVE Regulatory Specialist, creates and maintains all required documents for assigned regulatory binders; -Assist PIs, Regulatory Specialist, Core Project Manager in preparation for audits/monitoring visits 3) Data Management (20%) -Responsible for data management, data collection, data entry, and appropriate data storage for multiple projects. -Creates REDCap databases and enters study data 4) Outreach activities (10%) -Plan and participate local and regional outreach activities aimed at promoting awareness of MnDRIVE research study portfolio 5) Other duties as assigned (10%) Qualifications All required qualifications must be included in the application materials Required Qualifications: -BA/BS or a combination of related education and work experience to equal 4 years -Experience in the preparation of IRB applications -Working knowledge of regulations governing research activities (such as GCPs, FDA regulations and ICH guidelines) -Demonstrates 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: -Minimum of one (1) year experience in clinical research setting in an academic health center -BA/BS with at least two (2) years of experience or a combination of related education and work experience to equal 6 years -Certification as a clinical research professional with SoCRA or ACRP or willingness to obtain certification at time of eligibility. -EPIC experience -MATLAB experience -EEG/DBS/MEG/fMRI experience -Human psychophysics experience About the Department The Herman-Darrow lab studies decision-making in neuropsychiatric disorders in humans and develops novel neural-circuit biomarkers and neuromodulation approaches for treatments. See our website: . 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 Un versity 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 employ@umn.edu 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 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: Employment Requirements Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment. About the U of M The University of Minnesota, Twin Cities (UMTC) The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for... 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.