Clinical Research Manager, CTMS Support Unit | University of Chicago (UC) - Military Veterans

Location: Chicago, IL Job Description: Leads a team responsible for building OnCore protocol calendars and conducting coverage analysis as a service to the University of Chicago research community. Leads the determination of whether proposed clinical research studies are a qualifying clinical trial (QCT) as defined by the Medicare Clinical Trial Policy (NCD 310.1); designate medical procedures/services based on relevant regulations and determinations. Serves as an expert institutional resource related to Medicare billing rules and a functional expert on the internal process supporting compliant clinical research billing including OnCore calendar creation and validation. Performs OnCore protocol calendar build and coverage analysis tasks in support of team productivity and quality assurance. Investigates, modifies, and applies new procedures, techniques or applications of technology. Establishes goals and operating procedures, practices, and guidelines. Understands the applicable federal and state coverage regulations and identifies the research organization's role in regulating human research participation. Aids in development of departmental standard work and standard operating procedures. Leads process improvement within the OCR and across UChicago clinical research enterprise by collaborating on the development of policies, procedures, and recommendations.  Supervises a team of clinical research analysts. Advises on the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements. Leads and provides expertise in the implementation of compliance activities designated by the University's strategic plans. Monitors University compliance with regulations and laws. Represents the University in regulatory proceedings before federal, state and local agencies. Prepares the University's position statements and responses to information requests. Leads and manages audit responses and negotiations with administrative agencies. Performs other related work as needed. Preferred Qualifications Education: Advanced degree in a related field. Experience: People management and demonstrated ability to support a high functioning team. Clinical research experience such as clinical research conduct, regulatory compliance, or related research activities. Coverage analysis experience. Technical Skills or Knowledge: Proficiency with computer software systems such as Clinical Trial Management System. Knowledge of medical technology. Knowledge of relevant Federal and state regulations. Preferred Competencies Strong people management skills including training and support. Interpret research protocols, budgets, and consent forms to extrapolate billing/coverage information. Problem-solve, leveraging information and expertise available. Strong organizational skills. Manage projects at various stages of completion. Manage high volume of workload and meet deadlines. Demonstrated attention to detail. Working Conditions Office environment. Application Documents Resume/CV (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. The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.