University of Chicago

University of Chicago

Compliance Auditor

Chicago, IL, USA · Mid · Contract

Sponsorship not specified$65k-$90kDetected 1 day ago
GCPStatisticsComplianceProject ManagementExcelAuditingClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationMicrosoft OfficeGxPRegulatory Affairs

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About the role

  • With a moderate level of direction, participates in compliance documentation and compliance training.
  • 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

  • Plans and executes internal audits and monitoring activities to support regulatory agency inspections.
  • Provides training to faculty and staff to build knowledge of research compliance topics.
  • develops summary reports to support operational improvement efforts.
  • Supports HRPP initiatives by trending, tracking, and setting targets to measure the impact of compliance activities.

Requirements

  • include a college or university degree in related field.
  • When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Nice to have

  • 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).

Skills

  • 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.
  • Strong analytical, organizational, and report writing skills.
  • Ability to evaluate research records and documentation for accuracy, completeness, and compliance.
  • Familiarity with large healthcare information systems and/or EPIC.
  • Capacity to interpret research protocols, regulatory documentation, and institutional policies.
  • Office environment.
  • Resume (required)
  • Cover Letter (required)

Compensation

  • $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.
  • 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.
  • 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.

Benefits

  • 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.
  • Benefits Eligible

Equal opportunity

  • 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.
  • Job seekers in need of a reasonable accommodation to complete the
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This listing is sourced directly from University of Chicago's careers page and normalized into a canonical job model.