Job Description:

• Provide advisory services to faculty and staff in the research project planning, project initiation, conduct, and closeout phases of the clinical research lifecycle to enable knowledge transfer and skill building, offer solutions and best practices, facilitate connections to subject matter experts, and ensure resolution of issues or challenges inhibiting clinical research activity. 
• Provides regulatory subject matter expertise to faculty and staff in the planning phases of federally regulated clinical trials to ensure efficiency, accuracy, and compliance. 
• Oversees and enhances the research training program. Develops tools, guidelines, and training programs that enable the compliant conduct of research in fulfillment of regulatory requirements.
• Works collaboratively with departments, centers, and service lines in which clinical research operations take collect and evaluate research community needs, ensure implementation of process enhancements, build community, and establish a culture of research excellence across the enterprise. 
• Business system owner for clinical trial management system (CTMS), research module of electronic health record, and other systems utilized to support research activities. Responsibilities include but are not limited to driving continuous improvement (development of roadmap) from the business perspective, development and maintenance of training materials in collaboration with information technology teams responsible for system management.
• Ensures clinical research process and workflow optimization across the BSD, University, and UChicago Medicine through identification and exploration of pain points. Partners with stakeholders within Clinical Operations, Pharmacy, IT, Finance, Compliance, and Research. 
• Monitors trends, changes, and new developments in federal, state, and local research regulations, laws, and guidance documents to ensure research operations and processes adhere to current requirements and industry best practices.
• Measure and report KPIs and lead continuous improvement.
• Monitors project management and ensures that clinical trials are conducted in compliance with federal and institutional regulations. Manages, monitors and reports project budgets and annual projections. 
• Develops departmental plans, including strategic initiatives for the department, in collaboration with departmental and divisional leadership. 
• Advises faculty and research staff on all facets of clinical trial research management, including research conduct and compliance. 
• Performs other related work as needed.
   

Preferred Qualifications

Education:

• Master's preferred

Experience:

• Experience overseeing research billing compliance
• Experience advising academic and hospital leaders on research compliance risk mitigation
• Participation in conference talks, publications, or other thought leadership in clinical research compliance

Licenses and Certifications:

• Compliance credentialing through HCCA
• ACRP / SOCRA research certification

Preferred Competencies

• Knowledge of policies, procedures and legislation concerning human subjects in research and a basic understanding of the Code of Federal Regulations required. 
• Expert knowledge of ICH E6 Good Clinical Practices and regulations of clinical research set forth in the Code of Federal Regulations, the Office for Human Research Protections, Food and Drug Administration, National Institutes of Health and Center for Medicare and Medicaid Services or other relevant agencies required.
• Proven record of building effective working relationships across functions.
• 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 required. 
• Ability to network and interact, as well as support effective partnerships with key groups and individuals required. 
• Knowledge of Microsoft Word, Excel, Outlook and PowerPoint software required. Excellent organizational skills required. 
• Ability to work with minimal supervision and function as a team member required. 
• Attention to detail required. 
• Ability to prepare accurate documentation of events required. Ability to maintain confidential material and information required. 
• Excellent written and verbal communication skills to effectively interface with pharmaceutical industry, the hospital and departments within the Division required. 
• Ability to resolve issues, problem solve and make effective recommendations required.

Working Conditions

• Office Environment, ADA compliant

Application Documents

• Resume (required)
• Cover Letter (preferred)

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 the Applicant Inquiry Form.

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