OCCUPATIONAL SUMMARY
Leading audits and/or compliance assurance reviews of Duke University and/or Duke University Health System and its departments, institutes, centers, and regulatory functional offices to ensure effectiveness of internal controls and accuracy of recorded data. Performs operational, financial compliance and information technology assessments to evaluate business processes and technology systems for efficiency, effectiveness, and accuracy. May also conduct advisory engagements focused on risk assessment, root cause analysis, performance metrics, process design, and technology pre-implementation.
WORK PERFORMED
- Conduct risk-based monitoring, audit, and compliance assurance reviews across all aspects of clinical research including 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.
- Communicate and collaborate with team members, department leadership, and client representatives.
- Plan and perform independent, objective audit and advisory service engagements based upon understanding risks, developing scope, and project management against milestones.
- Compile information and/or prepare written reports and analyses communicating review results with appropriate recommendations to senior leadership; perform follow up to ensure complete and appropriate action within risk tolerance parameters.
- Examine and analyze records and conduct client interviews to evaluate internal controls, business process design, risk mitigation strategy, and/or compliance with Duke policy or third-party regulations.
- Lead risk-based engagement planning, perform fieldwork, document workpapers, and draft engagement reports.
- Develops recommendations to address issues detected.
DEPARTMENTAL PREFERENCES
Education/Training
Bachelor's degree in accounting, economics, management information systems, or related field; advanced degree desirable. CPA, CIA, CRA, CCRP or other relevant professional certification is strongly preferred.
Experience
Successful candidates will possess solid business acumen, well-developed analytical skills, strong relationship management abilities, and the desire to achieve value-added project outcomes.
Position requires at least five years' experience in auditing, accounting or financial operations, including responsibility for engagement planning, oversight, and delivery. Experience in public accounting, or equivalent professional services is preferred.
Experience in clinical research or regulatory compliance preferred. Knowledge of Good Clinical Practice (GCP) and Uniform Guidance regulations strongly preferred.
CORE COMPETENCIES
Technical Skills
- Research and investigation
- Business process documentation
- Risk and control identification
- Data collection and analysis
- Workpaper documentation
- Problem solving tools and techniques
- Project management
Interpersonal Skills
- Supportive of Duke Values
- Purpose driven
- Influence and communication
- Leadership and teamwork
- Change management
- Diplomacy and conflict resolution
The above statements describe the general nature and level of work performed by individuals assigned to this classification.
This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
MINIMUM QUALIFICATIONS
Education
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.
Experience
Requires five years experience in regulatory compliance, clinical research or grants administration.
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.