Help assist Resident physicians with IRB applications for study projects. Responsible for all regulatory documentation for all department clinical trials, safety reports, reporting of AE's and yearly renewals. Liaison between department and the University IRB staff.
30% Participate in Patient Study Visits
Determine eligibility of potential subjects on assigned studies, randomizes/registers eligible subjects to appropriate studies. Coordinates all study visits, monitors drug accountability, and all patient assessments.
Monitors AE's per study requirements and reports to sponsors.
20% Study Budget
Completion of study budgets and monitoring incoming study payments.
Maintaining the TASCS system with all study patients. Entering all study subjects visits appropriately to make sure patient billing is accurate. The system separates out those items set up to be billed to insurance and those to be billed to the study.
10% Patient Case Report
Maintain patient case report forms for accuracy, quality of data, timeliness of submission and compliance with each protocol. Coordinate preparation, implementation, and follow-up for audits/monitoring visits.
10% Department Study Support
Coordinate research studies for other departments who require ophthalmology services for eligibility. Work with patients to schedule appointment, be present for the exam, complete all required source documentation for primary Clinical Research Coordinator.
This position is on campus up to 50% time.
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
All required qualifications must be documented on application materials.
BA/BS with at least the equivalent of 2 full-time years' work experience or a combination of related education and work experience to equal 6 years.
Detail-oriented with exceptional organizational, planning, and problem-solving skills.
Ability to work independently, as a part of a team and with changing priorities.
Demonstrated ability to maintain deadlines and prioritize assignments.
Excellent written, verbal, and interpersonal skills.
Experience working in a clinical setting.
Experience with data storage, data management, and data analysis.
Experience with participant recruitment in a clinical setting.
Internal Number: 340256
About University of Minnesota, Twin Cities
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.