| 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 |
