Study Start-Up - 40% of time

• Participate in site qualification visits and protocol training sessions with industry sponsors
• Prepare and complete Institutional Review Board (IRB) applications in coordination with sponsoring companies and investigators
• Facilitate appropriate ancillary review processes
• Serve as liaison between investigators, sponsors, and regulatory committees
• Ensure regulatory compliance throughout the duration of the study
• Maintain study regulatory binders
  Negotiate budgets with sponsoring companies under guidance of Clinical Trials Manager
  Create protocol calendars in OnCore
  

Study Participant Recruitment and Management - 50% of time

• Initiate and run participant recruitment efforts
• Consent and enroll appropriate participants with regards to established protocols
• Coordinate participant study visits
• Schedule appropriate clinic appointments, procedures, testing, labs, and imaging studies per study protocol requirements
• Prepare lab kits and provide investigational devices/drugs as necessary
• Ensure appropriate billing designation for study visits by maintaining compliance in OnCore and EPIC systems
• Manage study data
• Collect appropriate study data directly (i.e. assess adverse events and protocol deviations, administer questionnaires, etc.) and from electronic medical records
• Enter data into sponsor eCRF platforms and address queries as needed
• Create and maintain subject binders with appropriate study CRFs and source documents
• Coordinate and oversee monitor visits by sponsors and audits by Human Research Protection Program (HRPP)

Research Assistant to Faculty and Staff - 10% of time

• Assist with protocol development as needed
• Assist with grant proposals and pricing as needed
• Miscellaneous administrative duties and assignments as requested

All required qualifications must be documented on application materials

Required Qualifications:

• BA/BS plus 2 years experience or combination of related education and work experience to equal 6 years.
• Experience working with healthcare data
• Knowledge of research methodology

Preferred Qualifications:

• Previous University of Minnesota research experience
• Previous experience coordinating clinical research
• Strong written and oral communication skills.
• Demonstrated ability to work independently and as part of a team.
  
  

To learn more about the Department of Urology, please visit:

• Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
• The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations
• Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.

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.

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.

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:

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.

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).