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Clinical Research Manager, CTMS Support Unit
University of Chicago
Chicago (IL)
On-site
USD 110,000 - 160,000
Full time
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Job summary
The University of Chicago is seeking a Clinical Research Manager for the CTMS Support Unit. This pivotal role will lead clinical trials, manage a dedicated team, and ensure compliance with medical regulations, ultimately advancing cutting-edge healthcare research. Suitable candidates will possess extensive experience in clinical research, project management, and a strong educational background.
Benefits
Qualifications
- Minimum 7+ years of related work experience.
- Experience in project management and team leadership.
- Proficiency with CTMS and knowledge of federal regulations.
Responsibilities
- Leads a team managing clinical trial processes.
- Develops and oversees protocols for coverage analysis.
- Ensures compliance with federal and state guidelines.
Skills
Education
Tools
Job description
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Department
BSD OCR - Operations Infrastructure Support
Department
BSD OCR - Operations Infrastructure Support
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
Minimum requirements include a college or university degree in related field.
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
Certifications:
Preferred Qualifications
Education:
- Advanced degree in a related field.
- 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.
- Proficiency with computer software systems such as Clinical Trial Management System.
- Knowledge of medical technology.
- Knowledge of relevant Federal and state regulations.
- 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.
- Office environment.
- Resume/CV (required)
- Cover Letter (preferred)
Job Family
Legal & Regulatory Affairs
Role Impact
Individual Contributor
Scheduled Weekly Hours
40
Drug Test Required
No
Health Screen Required
No
Motor Vehicle Record Inquiry Required
No
Pay Rate Type
Salary
FLSA Status
Exempt
Pay Range
$110,000.00 - $160,000.00
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
Yes
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.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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: http://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.
- Seniority levelMid-Senior level
- Employment typeOther
- Job functionResearch, Analyst, and Information Technology
- IndustriesHigher Education
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