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COMPLIANCE SPECIALIST

Job Title: COMPLIANCE SPECIALIST
Job Code: 0014
FLSA: N
Job Level: 11
Revised Date: 09/01/2008
Job Family: JF 03

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Occupational Summary

Assist in compliance audits of Duke University School of Medicine departments, institutes, centers, regulatory functional offices, and specific clinical trials and basic sciences research protocols to ensure data integrity, compliance with federal and state regulations pertaining to but not limited to: human research data integrity, clinical trials billing, effort reporting, conflict of interest, grant accounting (OMB Circular A-21 compliance).

Work Performed

Perform pre-analysis of protocols including the generation of roadmaps of procedures and expectations to be used during the audit process.

Compile of IRB documentation specific to studies to be audited.

Create flow sheets/data base for analysis of billing component of audits.

Generate Intent to Review letters to Study teams, including follow up letters, closing meeting documentation based on the key personnel lists to be gathered from multiple online sites.

Schedule audits through coordination of multiple calendars in numerous offices.

Assist with IRB risk matrix selection of studies to be reviewed each quarter.

Review internal controls, policies, and procedures to ensure compliance with appropriate University, State, and Federal guidelines and policies, sound business and finance practices, and overall clinical goals and objectives.

Respond promptly to external and internal concerns; implementing corrective actions as appropriate.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being 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.

Required Qualifications at this Level

Education/Training

Work generally requires organizational, analytical and communication skills normally acquired through the completion of a bachelor's degree program.

Experience

Work requires a minimum of 2 years experience in compliance or auditing setting, in a large and complex organization, such as a large public or private university, hospital or large healthcare provider.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills


The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


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.