合规审计员
Compliance Auditor
**部门** BSD OCR - 人类主体保护 ** 关于部门** 人类研究保护计划 (HRPP) 是通过开发和支持与临床和转化研究相关的特定监管基础设施组件来推进芝加哥大学生物科学部和芝加哥医学中心的任务。HRPP 专注于三个服务领域：人类主体防护 (IRB);合规性；教育和培训。**工作总结** 该职位维护了监管遵守方案，包括解释系统识别风险区域并协调内部审计。合规审计师维护和推进临床研究运营的监管合规计划，进行审核，监测活动和质量保证评估以确定风险并推动持续改善。该职位准备正式审计报告，追踪纠正和预防行动，并作为对研究合规性的主题资源。在适度指导下，角色参与了合规文件，培训和委员会的活动。**责任** - 协助确定 HRPP 年度研究合规审计计划的优先事项，并进行定期和针对性审计以评估机构政策，GCP 以及联邦，州和地方法规的遵守。- 规划并执行内部审计和监测活动来支持监管机构的检查。-审查学习生命周期文件包括批准，修改，注册数据和协议记录鉴定不一致，缺失信息和数据质量问题。- 评估与研究激活，维护，修正，注册和关闭活动相关的制度 SOP 和流程的遵守。- 编制书面审计和调查报告，概括观察，风险领域，趋势以及建议的纠正和预防行动 (CAPA). - 对所有发现缺陷的补救行动计划进行审查并跟踪降低风险的干预措施的有效性。- 向主要研究人员，研究团队和机构利益相关者传达结论，提供清晰的指导关于修复步骤和过程改善。- 追踪和趋势研究合规指控，调查，一项报告。
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**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**
**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:**
**---**
**Preferred Qualifications**
**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.
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](http://mybenefits.nfp.com/UChicago/benefits-guide/) [.](http://mybenefits.nfp.com/UChicago/benefits-guide/)
**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.](http://www.uchicago.edu/about/non_discrimination_statement/)
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.](http://uchicago.service-now.com/services?id=services_sc_cat_item_request&sys_id=8ff79243dbe91c1029f52ad94b961946)
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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