Urology Clinical Research Coordinator (Research Pro 2)
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
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
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.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.