COMPLIANCE AUDITOR, SENIOR
COMPLIANCE AUDITOR, SENIOR
Compliance and Privacy
Senior Compliance Auditor - Research Compliance Assurance
Assist the University Compliance Officer in designing and executing a research compliance program involving reviews of Duke University departments, institutes, centers, regulatory functional offices, and specific clinical trials and basic sciences research protocols to ensure compliance with institutional policies and procedures, state and federal regulations. The research compliance program will produce holistic research integrity assurance that will be used to support reporting to executive leadership and Duke's Audit, Risk, and Compliance Committee.
Conduct risk-based compliance assurance reviews across all aspects of research. Reviews will focus on the effectiveness of clinical research practices and grant and contract compliance which include but are not limited to assessments of culture and processes that support human subject protection and scientific quality and accuracy. Training, research monitoring, response to detected problems, and balancing the regulatory burden are key pillars for assessment of clinical research effectiveness.
Review and test for 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.
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.
Compile information and/or prepare reports and analyses setting forth results of compliance assurance reviews with appropriate recommendations to senior leadership; perform subsequent reviews to ensure complete and appropriate corrective action within risk tolerance parameters.
Assist in risk assessments and preparation of work plans.
Perform other related duties incidental to the work described herein.
Candidates for the position must possess substantive sponsored research and clinical trial knowledge, ability to write and verbally communicate complex subjects simply and effectively, demonstrate leadership and influencing skills, and commitment to collaborate with senior leadership to assist in risk management capabilities in support of the overall research mission.
CENTRAL ADMIN MANAGEMENT CTR
3802 COMPLIANCE AUDITOR, SENIOR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University 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 essential job 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.
Work requires a Bachelor's Degree in accounting, scientific, allied health or related field of study. Certified Research Administrator and/or Master's Degree preferred.
Requires five years experience in legal, regulatory compliance,clinical research, or grants administration.For those Compliance Auditors who will be performing CTQA human subjects research compliance reviews, SoCRA CCRP certification is a requirement to perform independent human subjects audits.For those Compliance Auditors conducting HIPAA/HITECH reviews in the School of Medicine Compliance Office, HCCA CHPC certification is a requirement to perform independent HIPAA/HITECH reviews and risk assessments. Knowledge of federal research compliance regulations including OMB Circular A-21 is required.Equivalent combination of relevant education and/or experience.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.