About the Department
The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. To provide the highest level of support and resources, the Office of Clinical Research is divided into two groups- the Institutional Review Board Administrative Staff (IRB) and the Research Operations and Conduct group (ROC). The OCR focuses on six key areas of service including: Human Subject Protection (IRB); Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure.
The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation
Clinical Research Compliance Audits
- 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.
Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
- 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.
- 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.
- Office environment.
- Resume (required)
- Cover Letter (required)
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University’s Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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