Identify and monitor potential privacy risks and create corrective action. Work with DUHS Departments to develop effective privacy education and training programs, including orientation and annual training. Monitor regulatory change, assist appropriate DUHS areas to implement or revise process to ensure compliance with privacy regulations. Perform other related duties incidental to the work described herein.
Duties and Responsibilities of this Level
Manage privacy audits of operational staff's access to patient information; and investigate and resolve policy violations.
Identify privacy risk areas, particularly in the area of clinical research, conduct focused privacy reviews, conduct trending analysis, and direct facility/departments to implement corrective action.
Develop internal controls, policies, and procedures to ensure compliance with appropriate Duke Health policies, State and Federal guidelines.
Investigate patient/research participant complaints and inquiries.
Collaborate with administrators and HR staff to implement corrective action to address violations of policy and regulations and manage completion of corrective action.
Support DUHS privacy activities, specifically as it relates to clinical research operations, including the following:
Develop and maintain policies and procedures related to use and disclosure of individually identifiable health information, in accordance with Duke Health policies, procedures, state/federal laws and best business practices.
Assist and coordinate development and delivery of departmental privacy/research trainings concerning privacy policies and procedures, protecting patient protected health information and release updates on new or updated policies, procedures and regulations.
Routinely present privacy trainings to bring awareness to privacy-related changes/updates to rules and regulations. Work with staff to modify workflows to ensure compliance and best practices are utilized.
Provide guidance to Duke Health workforce members, including clinical research units, Duke Office of Clinical Research (DOCR), and Duke Clinical Research Institute (DCRI), on privacy-related questions, and timely address privacy-related issues and/or concerns that may arise during patient/study participant engagement, patient encounters, research studies and/or exempt/quality improvement projects.
Write privacy-related articles in monthly departmental newsletter, Compliance Quarterly, as well as DOCR Newsletter. Notify staff of privacy/compliance updates, announcements and informational guides for staff via Compliance intranet.
Perform other related duties incidental to the work described herein.
Required Qualifications at this Level
Work requires a general business background generally equivalent to a Bachelor's degree in a business administration, accounting, management, healthcare administration, other related degree.
Strongly preferred: a graduate degree in information security, law, life sciences, or other related degree.
Four years of experience related to legal, regulatory compliance, patient advocacy, supervisory role in patient financial services or HIM services, or other relevant experience.
Strongly preferred: Five years of experience related to legal, clinical research, regulatory compliance, or other relevant experience.
Degrees, Licensure, and/or Certification
Knowledge, Skills, and Abilities
In depth and working knowledge and experience with applicable federal regulations including, HIPAA, Common Rule, FDA Clinical Trials (drug/device), is preferred.
Strong oral and written communication skills.
Demonstrated experience with problem solving, analytical, critical thinking, managing a busy caseload; functions as a strong team player; effective written and oral communication skills; working knowledge of privacy regulations; strong knowledge of MS applications including excel and a general understanding of technology.
Experience conducting investigations in a healthcare-related field is preferred.
Certification in HIPAA Privacy/Security, Healthcare compliance, or applicable experience is preferred.
Distinguishing Characteristics of this Level
Skilled at spotting health research-related compliance issues and thoroughly investigating issues to their conclusion without supervision.
Experienced navigating large academic health research organizations.
Holds a certification in one or more of the following: CIP, CHPS, RHIT, CHRC, CIPP/US, or similar research and privacy certifications.
At least 5 years' experience submitting or reviewing human subject research to an IRB involving retrospective health information.
At least 5 years' experience auditing electronic files, data flows, folder permissions for HIPAA-related audits.
At least 5 years' experience coordinating and developing auditing processes; developing and implementing policies and procedures; conducting investigations and drafting recommendations for corrective measures.
A graduate degree in information security, law, or life sciences.
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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.
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