Clinical Research Coordinator (Research Pro 2)- Dept. of Urology

Surgical Administrative Center- University of Minnesota


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  • Minneapolis, MN
    Surgical Administrative Center- University of Minnesota
    Nov 19, 2020

*Required (must be mentioned on application/resume):

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.

Job Responsibilities:

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

The University of Minnesota offers a comprehensive benefits package including:

  • competitive wages, paid holidays, vacation and sick leave
  • Low cost medical, dental, and pharmacy plans
  • Healthcare and dependent daycare flexible spending accounts
  • Excellent retirement plans with employer match
  • Disability and employer paid life insurance
  • Wellbeing program with reduced insurance premiums
  • Tuition reimbursement opportunities covering 75%-100% of eligible tuition
  • Student loan forgiveness opportunity
  • Opportunities for growth and promotion
  • Employee assistance program

For more information regarding benefits, please click here.

 

To Apply for this job, click here. Please search by Job Opening ID 338273