Job Duties/Responsibilities: Duties include but are not limited to providing:
1) Clinical Research Coordination (50%): - 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 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 (10%) -Responsible for data management, data collection, data entry, and appropriate data storage for multiple DBS 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%) 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
- Health care 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: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2018_tcd-cslr-75100-ben-0105-7.pdf |