Compliance Auditor

Biological Sciences Division at the University of Chicago; Chicago (IL); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

The Biological Sciences Division at the University of Chicago is seeking a Compliance Auditor to maintain regulatory compliance programs for clinical research operations. You will interpret systems to identify risk, coordinate internal audits, and prepare formal reports with CAPAs.

With 2–5 years of related experience and knowledge of GCP and IRB processes, you will train staff, monitor trends, and provide SME guidance to investigators.

Competenze

• Minimum requirements include a college or university degree in related field.
• 2-5 years of work experience in clinical research regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.
• CITI Human Subject Protection & Good Clinical Practice experience strongly preferred; knowledge of 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH guidelines is preferred.

Mansioni

• Identify priorities for the HRPP annual research compliance audit plan and conduct routine and targeted audits for policy and regulatory compliance.
• Plan and execute internal audits and monitoring activities to support regulatory inspections.
• Review study lifecycle documents for discrepancies and data quality issues.
• Evaluate adherence to SOPs and processes related to study activation, maintenance, amendments, enrollment, and closure.
• Prepare audit reports, track CAPAs, and communicate findings to investigators and stakeholders.
• Monitor corrective action plans and assess intervention effectiveness.
• Provide training to faculty and staff on research compliance topics.
• Collaborate on cross-division projects to increase efficiencies and risk mitigation.
• Support ClinicalTrials.gov and coordinate compliance documentation and meetings.

Conoscenze

Communication skills

Analytical skills

Organization

Project management

Formazione

Bachelor's degree in related field

Strumenti

Microsoft Office

Electronic IRB systems

Clinical trial management systems

Descrizione del lavoro

About The Department

The Human Research Protections Program (HRPP) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific regulatory infrastructure components related to clinical and translational research. The HRPP focuses on three areas of service: Human Subject Protection (IRB); Compliance; and Education and Training.

Department

BSD OCR - Human Subjects Protection

About The Department

The Human Research Protections Program (HRPP) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific regulatory infrastructure components related to clinical and translational research. The HRPP focuses on three areas of service: Human Subject Protection (IRB); Compliance; and Education and Training.

Job Summary

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and coordinate internal audits. With a moderate level of direction, participates in compliance documentation and compliance training. The Compliance Auditor maintains and advances the regulatory compliance program for clinical research operations, conducting audits, monitoring activities, and quality assurance assessments to identify risk and drive continuous improvement. The position prepares formal audit reports, tracks corrective and preventive actions, and serves as a subject matter resource on research compliance. With moderate direction, the role participates in compliance documentation, training, and committee activities.

Responsibilities

• Assists in the identification of priorities for the HRPP annual research compliance audit plan and conducts routine and targeted audits to assess compliance with institutional policies, GCP, and federal, state, and local regulations.
• Plans and executes internal audits and monitoring activities to support regulatory agency inspections.
• Reviews study lifecycle documentation—including approvals, amendments, enrollment data, and protocol records—to identify discrepancies, missing information, and data quality issues.
• Evaluates adherence to institutional SOPs and processes related to study activation, maintenance, amendments, enrollment, and closure activities.
• Prepares written audit and investigation reports summarizing observations, risk areas, trends, and recommended corrective and preventive actions (CAPAs).
• Reviews all corrective action plans for identified deficiencies and tracks the effectiveness of interventions for risk mitigation.
• Communicates findings to principal investigators, study teams, and institutional stakeholders, providing clear guidance on remediation steps and process improvements.
• Tracks and trends research compliance allegations, investigations, and outcomes.
• Serves as divisional subject matter expert regarding clinical research compliance.
• Provides training to faculty and staff to build knowledge of research compliance topics.
• Contributes to the development and maintenance of monitoring plans, review methodologies, audit procedures, and quality assurance metrics.
• Analyzes monitoring outcomes to identify trends, recurring issues, and systemic risks; develops summary reports to support operational improvement efforts.
• Supports HRPP initiatives by trending, tracking, and setting targets to measure the impact of compliance activities.
• Collaborates with Clinical Research Stakeholders on cross-division projects focused on increasing efficiencies and risk mitigation.
• Provides support for ClinicalTrials.gov.
• Coordinates department or clinic compliance with a moderate level of guidance.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• 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 2-5 years of work experience in a related job discipline.

Experience

• 2-5 years of work experience in clinical research regulatory compliance, study coordination, quality assurance, monitoring, auditing, or related research activities.
• CITI Human Subject Protection & Good Clinical Practice experience strongly preferred.
• Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines experience strongly preferred.
• Prior auditing, monitoring, or quality assurance experience strongly preferred.
• Familiarity with the ClinicalTrials.gov system strongly preferred.
• Experience with electronic IRB systems strongly preferred.

Licenses And Certifications

• Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP).

Technical Skills Or Knowledge

• Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Teams.
• Demonstrable organizational and project management skills.
• Experience with electronic IRB or clinical trial management systems.

Preferred Competencies

• Strong analytical, organizational, and report writing skills.
• Ability to evaluate research records and documentation for accuracy, completeness, and compliance.
• Ability to interpret research protocol information in relation to federal guidelines and internal policies; exercise sound judgment and make recommendations regarding research policies.
• Familiarity with large healthcare information systems and/or EPIC.
• Capacity to interpret research protocols, regulatory documentation, and institutional policies.
• Excellent interpersonal and communication skills (oral/written), including the ability to communicate findings effectively through written reports and presentations.
• Demonstrated attention to detail and ability to manage a high volume of work and meet deadlines.
• Ability to work as part of a collaborative team as well as autonomously.

Working Conditions

• Office environment.

Application Documents

• Resume (required)
• Cover Letter (required)

The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions.

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 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.

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