Clinical Research Manager, CTMS Support Unit

The University of Chicago; Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

The University of Chicago seeks a Research Manager to lead project management and quality control for clinical trials within the Office of Clinical Research. This role is pivotal in shaping healthcare advancements through effective management and compliance with regulations, alongside nurturing a high-performing team to oversee clinical research initiatives.

Benefits

Comprehensive health benefits

Retirement plans

Paid time off

Professional development opportunities

Qualifications

• Minimum 7+ years of work experience in a related job discipline.
• Advanced degree in a related field preferred.
• Experience in clinical research or regulatory compliance preferred.

Responsibilities

• Lead project management and quality control for clinical trials.
• Manage a team responsible for building OnCore protocol calendars.
• Serve as an expert resource on Medicare billing and compliance.

Skills

Project Management

Quality Control

People Management

Regulatory Compliance

Problem-solving

Education

College or university degree in related field

Tools

Clinical Trial Management System (CTMS)

Job description

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

Education:

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:

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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)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

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.