Clinical Research Manager, CTMS Support Unit

Department
 

BSD OCR - Clinical Research Operational Excellence

About the Department
 

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.

Job Summary
 

As a Research Manager in the Office of Clinical Research, you will be at the heart of advancing cutting-edge medical trials, playing a pivotal role in shaping the future of healthcare. You will lead project management and quality control across a diverse array of trials— industry sponsored, multi-site, national, and investigator-initiated—guiding them towards breakthrough outcomes by leveraging the technology of a Clinical Trial Management System (CTMS).

Acting as a bridge between visionary stakeholders in the research community, you'll ensure that every step of the CTMS support service, from calendar build to coverage analysis, aligns seamlessly with the highest standards of institutional, federal, and state guidelines. You will lead a team of Clinical Research Analysts responsible for tasks such as coverage analysis, calendar creation, system training, and other functions of the clinical trial management system (OnCore). Your responsibility extends to nurturing talent; you will recruit, onboard, and train new staff, fostering an environment of excellence and innovation. By managing and supervising a dedicated team, you'll push the boundaries of what's possible, establishing institutional metrics that set the benchmark for clinical research performance.

Join us in this transformative journey to revolutionize clinical research processes and elevate biomedical research at the University of Chicago to unprecedented heights. Your leadership will be the catalyst for change, driving impactful discoveries that will benefit countless lives.

Responsibilities

• 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.

Minimum Qualifications
 

Education:

Minimum requirements include a college or