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Apply for Job Job ID363702 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P2 Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job Dr. Jo-Anne Young, clinical investigator in the Department of Medicine, Division of Infectious Diseases, is seeking a study coordinator to assist with the preparation and conduction of clinical research. 60%- Administrative Support for Clinical Trials Facilitate internal approvals, as required, by individual protocols: IRB, Caner Protocol Review Committee (CPRC) for oncology-related protocols, scientific review, Radiation Review Committee, Department of Medicine. Assist with budget development and negotiation. Facilitate SPA contract negotiations through the established process. Establish utilization of University of MN Medical Center, Fairview, Fairview and MHealth resources. Establish and maintain study binders with regulatory documentation. Update IRB and CPRC with protocol, informed consent, and regulatory documentation changes, as needed, based on amendments or other submitted documents. 30%- Study Functions Ensure protocol compliance Facilitate subject recruitment and screening, obtain subject consent, monitor compliance of study subjects to protocol, coordinate study visits and obtain biological samples required by the protocols. Timely data entry of all study subject data into case report forms and/or electronic databases. Communicate with PI and to the study team all relevant medical patient information to manage study subjects in a safe and responsive manner. Inform PI and clinical caretakers of adverse events and report Serious Adverse Events to protocol sponsors. Communicate and collaborate with study sponsors, and Investigational Review Board. -Assist study monitors with the site initiation visits, monitoring visits, and close out visits. Maintain patient confidentiality and compliance with HIPAA regulations. Manage clinical trials supplies. Facilitate closure of completed studies, including safe storage of study documentation. 10%- Communications Establish and maintain collaborative relationships with Investigational Pharmacy, BMT Patient Services, nursing, medical, laboratory and microbiology staff. Act as liaison with other health care personnel, providing information about current study protocols and assistance with patient enrollment. Maintain a good working relationship with the FDA Clinical Research Regulations and Good Clinical Practice (GCP) standards for Research. Other Duties as Assigned Qualifications Required Qualifications (Must be documented on all application materials): BA/BS in biological or health care-related field with 2 years of experience or a combination of education and work experience to equal 6 years Proficient computer experience to include Microsoft Word and Excel or similar software Previous experience working with patient databases and electronic medical records Demonstrated strong problem-solving skills, strong patient relation skills, and ability to work independently Willingness to assist in collection of body fluids (stool, urine, throat cultures, skin cultures), as required by study protocols. This does not include blood drawing, but blood samples will be handled. Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza Preferred Qualifications: Certified by ACRP or SOCRA as a Clinical Research Coordinator Previous clinical research experience, including data collection from study subjects and completing case report forms. Experience initiating clinical trials, including acquiring internal approvals, budget negotiations, documentation and regulation management. Demonstrated working knowledge of Federal Regulations, IRB/HIPAA guidelines, and good clinical practice guidelines. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and support ve 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 Regents Tuition Benefit Program 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) opportunity Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Please visit the Office of Human Resources website 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) 624-8647. Diversity 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 Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022). 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.