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RESEARCH COMPLIANCE PRINCIPAL AUDITOR - The Office of Audit Risk & Compliance (145388)

Work Arrangement: 
Requisition Number:  145388
Regular or Temporary:  Regular

Durham, NC, US, 27710

Date:  Aug 30, 2022

Work Hours

This position requires a hybrid work schedule which includes one day per week onsite


Occupational Summary:
Assist the Director Sponsored Programs Assurance and Research Compliance in designing and executing clinical research assurance reviews of Duke University departments, institutes, centers, and regulatory functional offices to ensure compliance with institutional policies and procedures, state, and federal regulations. The research compliance program produces holistic research integrity assurance that is used to support reporting to executive leadership and Duke's Audit and Compliance Committee.


Work Performed:

  • Conduct risk-based monitoring and compliance assurance reviews across all aspects of clinical research. Reviews will focus on the effectiveness of clinical research practices which include but are not limited to assessments of processes that support human subject protection, scientific quality and accuracy, training, monitoring, response to detected problems, and balancing the regulatory burden which are key pillars for assessment of clinical research effectiveness.
  • Assist in risk assessments and work plan preparation.
  • Review and test compliance with institutional policies and procedures, applicable laws, and regulations through the inspection of physical operations, retrieval and review of documents and investigation of irregularities and errors. Perform directed reviews requested by university leadership or internal or external oversight bodies and assist study teams with FDA for-causes it visits.
  • Compile information and/or prepare reports and analyses communicating review results with appropriate recommendations to senior leadership; perform follow up to ensure complete and appropriate corrective action within risk tolerance parameters.
  • Provide assistance and information, including periodic progress reports, to the Duke University compliance officer and various external or governmental auditors to facilitate their audits of University records.
  • Perform other related duties incidental to the work described herein.

Minimum Qualifications

Bachelor's Degree in accounting, scientific, allied health, or related field of study. Certified Research Administrator (CRA), Certified Clinical Research Professional (CCRP) or equivalent certification is preferred.



  • Requires five years' experience in regulatory compliance, clinical research, or grants administration.
  • Candidates for the position must possess substantive clinical trial and/or regulatory compliance (GCP/GLP) knowledge, ability to write and verbally communicate complex subjects simply and effectively, identify and interpret trends within a risk framework, demonstrate leadership, ability to influence and commitment to collaborate with senior leadership to assist in risk management capabilities in support of the overall mission.
  • Working knowledge of federal regulations and guidance related to human subject's protections. SoCRA CCRP or equivalent certification is preferred.



Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.


Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.


Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh