Compliance Auditor - Clinical Trials

At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.

General Description of the Job Class

Conduct health-system wide compliance audits to ensure data integrity, compliance with federal and state regulations pertaining to but not limited to: federal healthcare program requirements, coding and documentation and clinical trials billing.  Interpretation of applicable federal and state law & regulations to plan audit parameters, determine department’s compliance with such regulations and communicate to department necessary changes in compliance with regulatory requirements.  As well as, manage health system wide response to governmental audits to ensure data integrity and completeness of records and accuracy of claims.

Duties and Responsibilities of this Level:

• Responsible for conducting clinical trial compliance audits, documenting & communicating findings and recommendations, explaining regulatory requirements, and overseeing the corrective actions for audits within DUHS
• Manage activities related to monitoring requests and responses of governmental audits (e.g. RAC and Medicaid Program Integrity), monitor and trend activity, and oversee and monitor appeals.
• Conduct risk assessments and preparation of work plans.
• Develop an understanding of the operations, system processes and procedures used in areas being audited.
• Review and test for compliance with institutional policies and procedures, applicable laws and regulations through the inspection of physical operations, processes, retrieval and review of documents and investigation of irregularities and errors.
• Compile information and/or prepare reports and analyses setting forth results of compliance audits with appropriate recommendations; perform subsequent audits to ensure complete and appropriate corrective action.
• Develop recommended corrective actions to address issues detected.
• Actively participates in exit conferences, providing clarification and supporting information necessary.
• Performs other related duties incidental to work described above

Minimum Qualifications

Education

Work requires a general business background generally equivalent to a Bachelor's degree in a business administration, accounting, management, healthcare administration, nursing, other related degree.

Experience

• Four years of experience related to legal, and regulatory compliance, patient advocacy, supervisory role in patient financial services or HIM services, or other relevant experience.
• Experience with compliance auditing
• Experience independently performing and conducting compliance audits including the review of documentation, coding and billing.
• Prefer experience in clinical research, familiarity with protocols, clinical trials and clinical research studies.
• Experience with Federal clinical research process and regulations, including billing, coding and documentation requirements.
• Demonstrated experience working as part of the interdisciplinary team.
• Experience with EPIC and OnCore is preferred.
• Research, abstracts and communicates federal, state and payor documentation, billing and coding rules and regulations; stays current with Medicare and Medicaid rules and regulations, CPT, ICD, HCPCS, DRG and APC coding updates related to clinical research and serves as a subject matter expert

Degrees, Licensures, Certifications

Coding certification (e.g. CPC, CCS, RHIA, or RHIT), Research compliance certification CHRC or applicable experience is required.

Knowledge, Skills, and Abilities 

• Ability to be flexible, multitask, and switch priorities as well as work comfortably in a deadline driven / productivity environment   
• Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously
• In-depth knowledge of federal regulations around clinical trials
• EPIC, OnCore, and Microsoft Office experience 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.