Director, Clinical Research Systems and Compliance

University of Chicago • Chicago, IL

1d • $120,000 - $160,000 • Hybrid

About The Position

The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio. The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care. The job manages multiple related teams of managers and professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. This position serves as the business system owner for CTMS, OnCore, driving continuous improvement through development of a multi-year system roadmap and close partnership with IT teams overseeing technical management. Responsibilities include overseeing ongoing adoption of OnCore and the central study intake platform to ensure efficient study triage, accurate data capture, and seamless integration with enterprise research workflows. The role leads the technology and education pillar for research systems by designing processes, developing training materials, and implementing formal education programs for system end users. Additionally, this position mentors and develops clinical research professionals, fosters a culture of collaboration, and employs data metrics to deliver operational insights that inform strategic initiatives across the research systems application lifecycle. A key area of focus is the coverage-analysis service line, where the director provides strategic leadership to guarantee high-quality operations and compliance with CMS and institutional requirements. The position ensures the development and adherence to standardized workflows, formalized procedures, and accurate integration of coverage analysis findings into research operations, with a particular emphasis on downstream research billing compliance. Collaborating with finance, compliance, and research operations teams, the director promotes continuous process improvement, data-driven decision making, and the alignment of billing determinations with all applicable regulations. The role also monitors industry trends and evolving regulatory guidance to support the institution’s commitment to compliant and high-performing clinical research operations.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

Nice To Haves

• College or university degree in related field.
• Advanced degree in the sciences.
• 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.

Responsibilities

• 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.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees