Quality Assurance Auditor

Department
BSD CCC - Quality Core

About the Department
The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant funds ten Shared Resources. The Comprehensive Cancer Center comprises over 190 faculty members from twenty departments, with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer-reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management, and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.

Job Summary
The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and compliance committee formation.

This at-will position is wholly or partially funded by extramural funds (e.g., grant, gift, endowment) which is renewed under provisions set by the grantor. Your employment will be contingent upon the continued receipt of these extramural funds and your satisfactory job performance.

If this position is eliminated due to the discontinuation of extramural funding, you will be given a minimum of one pay period's written notice. (If exempt: 30 days, If non-exempt: 2 weeks), or pay in-lieu of notice.

Responsibilities

• Coordinates, manages, and conducts comprehensive internal audits for the University of Chicago Comprehensive Cancer Center (UCCCC).
• Conducts audits in a confidential and independent manner.
• Conducts internal audits as outlined in the UCCCC Data and Safety Monitoring Plan (DSMP), including: Investigator Initiated Trials (IITs) where UCCCC is the sponsor; studies under the National Clinical Trial Network (NCTN); and trials conducted at UCCCC with external sponsors (industry trials). Routine and for-cause audits may be conducted.
• Communicates audit findings to research staff.
• Reviews and approves Corrective and Preventive Action Plans that may be required as a result of the internal audit findings.
• Maintains overall metrics related to the number of audits conducted, the length of time each audit takes, and the number of corrective and preventive plans approved. These reports will be presented to the immediate supervisor and, as needed, to the UCCCC leadership team.
• Collaborates with the Education and Training manager on SOP revisions resulting from audit findings.
• Works collaboratively with the BSD office of Clinical Research (OCR) - Research Compliance Section.
• Coordinates department or clinic compliance with a moderate level of guidance.
• Plans and executes internal and external audits and activities to support regulatory agency inspections.
• 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 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Experience:

• Experience reading and understanding protocols on studies to be audited.
• Familiarity with federal and local regulations, Good Clinical Practice (GCP) guidelines and UCCCC Standard Operating Policies (SOPs).

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
• Strong organizational skills.
• Excellent interpersonal skills.
• Strong data management skills and attention to detail.
• Knowledge of the Microsoft Suite, including Outlook.
• Ability to understand complex documents (e.g., clinical trials).
• Ability to handle competing demands with diplomacy and enthusiasm.
• Ability to absorb large amounts of information quickly.
• Seamless adaptability to change in fast-paced environments.

Working Conditions

• Ability to navigate the UChicago Campus as required by the Position.
• Hybrid work arrangements may be considered.

Application Documents

• Resume (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
$65,000.00 - $90,000.00
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 View phone number on click.appcast.io 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.

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