Director, Clinical Research Systems and Compliance

* Act as business system owner for CTMS, OnCore, and the central intake system, ServiceNow. Responsibilities include but are not limited to driving continuous improvement through development of a multi-year roadmap and partnering with IT teams responsible for technical management.* Provide strategic oversight and responsibility for the coverage-analysis service line, ensuring high-quality day-to-day operations, compliance with CMS requirements, ongoing process improvements, and sustainable growth of the unit.* Oversee the central study intake platform and the staff responsible for intake operations, ensuring efficient study triage, accurate data capture, and alignment with enterprise research workflows.* Manage the technology and education pillar for research systems, including the design of workflows, development of training materials, and delivery of ongoing education programs for OCR offices and end users. Develop and oversee a formalized CTMS training program for new and existing staff within the unit and affiliated partners.* Lead, mentor, and develop a high-performing team of clinical research professionals, fostering a collaborative and innovative team culture.* Provide operational guidance to internal teams and other institutional stakeholders to ensure alignment of operations and strategy.* Develop and maintain Standard Operating Procedures and ensure adherence across the clinical research enterprise. Collaborate with institutional stakeholders to ensure compliance and optimization of processes.* Employ data metrics to deliver insights and recommendations that inform strategic initiatives throughout the systems application lifecycle.* Identify and implement best practices for clinical research workflows. Utilize process-improvement methodologies to enhance efficiency and effectiveness in study execution.* Partner with finance, compliance, research administration, and other stakeholders to ensure seamless integration of clinical research activities as it relates to enterprise system optimization.* Provide expert guidance on clinical research operations processes and serve as a resource for team members and collaborators across the institution.* Monitor 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.* Manages managers and professional staff to monitor financial transactions, revenues and expenditures for clinical research trials. Ensures all data is accurately recorded, utilizing institutional (accounting and research) policies.* 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.* Experience with Clinical Trial Management System (CTMS) and other enterprise solutions for research administration.* Experience managing a team of individuals.* Medicare Coverage Analysis knowledge and experience.* Knowledge of policies, procedures and legislation concerning human subjects in research and the Code of Federal Regulations.* 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.* Ability to interpret research protocol information in relation to federal requirements and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies. Expert knowledge of CMS billing rules (NCD, LCD) and Medicare Coverage Analysis best practices.* Experience leading highly functioning teams and overseeing managers and independent contributors.* Proven record of building effective working relationships across functions as well as support effective partnerships with key groups and individuals.* Expert knowledge of Microsoft Word, Excel, Outlook and PowerPoint software.* Excellent organizational skills.* Ability to work independently and drive work forward.* Attention to detail.* Ability to prepare accurate documentation and maintain confidential material and information.* Excellent written and verbal communication skills to effectively interface with pharmaceutical industry, the hospital and departments within the Division.* Ability to resolve issues, problem solve and make effective recommendations.When applying, the document(s) **MUST** be uploaded via the **My Experience** page, in the section titled **Application Documents** of the application.The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.To learn more about the university click here #J-18808-Ljbffr