Identifies priorities for OCR annual research compliance audit plan.
Conducts audits to document compliance with UChicago policies, GCP, Federal, state and local regulations.
Provides written audit and investigation reports, identifying risks and recommendations for interventions to improve effectiveness and mitigate risk.
Review all corrective action plans for identified deficiencies and track effectiveness of interventions for effectiveness and risk mitigation.
Track and rend research compliance related allegations, investigations and outcomes.
Clinical Research Compliance Training & Education
Contribute to divisional clinical research training portfolio, training plans, coordination of speakers and frequency of modules and topics.
Trend and analyze effectiveness of training offerings.
Serve as divisional subject matter expert regarding clinical research compliance.
Publish and maintain website with tools, templates and resources that support divisional clinical research compliance.
Clinical Research System Compliance Support
Divisional Trainer for Clinical Research systems within the electronic medical record, financial management systems.
Oversee system access for clinical research staff.
Metrics Development and Reporting
Support OCR initiative by trending, tracking and setting targets to measure impact of compliance activities.
Collaborate with Clinical Research Stakeholders for projects across the division focusing on increasing efficiencies and risk mitigation.
Plans and executes internal and external audits and activities to support regulatory agency inspections.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Performs other related work as needed.
CITI Human Subject Protection & Good Clinical Practice.
Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines.
Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies.
Familiarity with large healthcare information systems and/or past experience with EPIC experience.Â
Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP).
Strong analytical, organizational and report writing skills.
Excellent interpersonal and communication skills (oral/written).
Ability to work as part of collaborative team as well as autonomously.
Demonstrable organizational and project management skills.
Expertise in Microsoft Excel, Access, and PowerPoint.
Cover Letter (required)
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Internal Number: JR10458
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.