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- Serve as the John A. Burns School of Medicine's (JABSOM’s) subject matter expert for day-to-day compliance matters.
- Advise on a wide variety of clinical education & research compliance & risk management matters, including Health Insurance Portability & Accountability Act (HIPAA), Private Health Information (PHI), & other compliance and risk management matters.
- Lead and conduct senior-level policy analysis of any new or revised compliance & risk management regulatory requirements; develop policies & procedures as needed to assure the adequacy of JABSOM’s existing policies and systems.
- Develop & lead educational & training programs to help ensure faculty, staff, students, applicable contractors, researchers, & volunteers have knowledge of, & comply with, pertinent laws, rules, compliance & risk management regulations & policies.
- Serve as JABSOM’s HIPAA Privacy officer/unit coordinator, ensuring a timely & well-coordinated response to HIPAA privacy issues.
- In collaboration with JABSOM’s HIPAA Security officer/unit coordinator & UH System’s HIPAA Privacy/Security Office, assist in managing and expanding the visibility of a JABSOM corporate compliance program.
- Ensure that this corporate compliance program includes dissemination of information & provision of guidance regarding compliance with HIPAA Federal regulations & University & sponsoring agency policies and procedures.
- Monitor the healthcare & clinical research regulatory environment for emerging trends & assist JABSOM leadership in assessing any impact to the education & research function.
- Identify potential compliance vulnerabilities external to & within JABSOM & determine the level of risk; recommend to JABSOM’s compliance committee risk remediation, including an assessment of internal controls, as applicable.
- Monitor the implementation of corrective action plans &/or process improvements resulting from internal or external reviews, & approved recommendations from regulatory agencies.
- Coordinate & oversee regulatory submissions and reporting activities, including working with regulators & others to clarify & resolve issues.
- Frequently interact with the Office of General Counsel for assistance in interpretation of regulatory requirements &/or legal advice on issues, concerns &/or risks.
- Frequently interact with UH System Office of Research Services, Office of Research Compliance, & the Institutional Review Board to assist on regulatory matters in sponsored projects administration & the conduct and administration of clinical trials.
- Responsible for administering, monitoring, negotiating, recommending, & implementing JABSOM's professional liability insurance program in collaboration with University Health Partners of Hawai'i.
- Responsible for coordination of clinical research compliance activities in conjunction with JABSOM’s clinical & healthcare affiliates.
- Inform, advise & recommend actions for the JABSOM after consulting & receiving approval from the JABSOM compliance committee that includes the JABSOM Dean, Associate Deans, Chief Financial Officer, & the Designated Institutional Official.
- Prepare quarterly reports to compliance committee about progress & status of projects, including anticipated problems, major policy changes, & project implications related to HIPAA, PHI, medical malpractice, insurance risk, & other compliance matters.
- Resolve administrative matters in accordance with current policies, procedures, directives, & past practices.
- Initiate, and is responsible for, confidential & sensitive, as well as general written and oral communications, exercising tact, diplomacy, & good judgment in relation with others.
- Work as a team member to identify, coordinate, evaluate, & solve problem areas.
- Supervise subordinate employees assigned to respective unit.
- Other duties as assigned
- Possession of a baccalaureate degree in business administration or related field and 9 year(s) of progressively responsible professional experience with responsibilities for research, academic &/or clinical compliance matters; or equivalent education/training or experience.
- Advanced and comprehensive knowledge and understanding of a wide range of developing and emerging concepts, principles and methodologies of the assigned area of research, academic &/or clinical compliance.
- Comprehensive knowledge and understanding of a wide range of principles, theories, federal and state laws and systems associated with research, academic, &/or clinical compliance.
- Demonstrated ability to understand problems from a broad interactive perspective and use reasoning to discern underlying principles and issues when problem solving, and apply creative thinking to resolve problems in new and unprecedented approaches.
- Demonstrated written and verbal competence in presenting ideas, concepts and models clearly using persuasion and negotiation to build consensus and cooperation.
- Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team leaders and members, and individuals.
- Demonstrated ability to operate a personal computer and apply word processing software.
- For supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations.
- Demonstrated ability to exercise judgement and make effective decisions that significantly impact an organization, which includes its functions, programs, management, or policies of significant complexity &/or scope.
- Demonstrated ability to direct, lead, assign, organize, set objectives, & plan the work of an organization, which requires considerable original thought and foresight from technical, managerial, and/or administrative viewpoints.
- Demonstrated ability to effectively supervise, direct, assign, monitor, review, & evaluate the work of subordinate level professionals and estimate staffing needs & schedules, and assign work to meet deadlines & goals.
- Knowledge of the principles, practices, and techniques of governmental practices and negotiations specific to public and/or private colleges & universities.
- Expertise concerning federal & state laws & organizational policies regarding the maintenance of HIPAA and PHI related information.
- Any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.
- Master’s degree and 5 years of progressively responsible experience in the field of compliance.
- Demonstrated ability to successfully establish, advocate, & adhere to policies, practices, procedures, & principles in the best interest of the organization despite strong opposing views & opinions.
- Ability to exercise initiative by anticipating & proactively addressing compliance & operational issues or situations.
- Certification in Healthcare Research Compliance (CHRC) and/or Certified Healthcare Privacy Compliance (CHPC).
- Patricia Blanchette, MD; 808-692-0936
The University of Hawaiʻi is an equal opportunity/affirmative action institution and is committed to a policy of nondiscrimination on the basis of race, sex, gender identity and expression, age, religion, color, national origin, ancestry, citizenship, disability, genetic information, marital status, breastfeeding, income assignment for child support, arrest and court record (except as permissible under State law), sexual orientation, domestic or sexual violence victim status, national guard absence, or status as a covered veteran.
Employment is contingent on satisfying employment eligibility verification requirements of the Immigration Reform and Control Act of 1986; reference checks of previous employers; and for certain positions, criminal history record checks.
In accordance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, annual campus crime statistics for the University of Hawaii may be viewed at: http://ope.ed.gov/security/, or a paper copy may be obtained upon request from the respective UH Campus Security or Administrative Services Office.
In accordance with Article 10A of the unit 08 collective bargaining agreement, bargaining unit members receive priority consideration for APT job vacancies. As a result, external or non BU 08 applicants may not be considered for some APT vacancies. BU 08 members with re-employment rights or priority status are responsible for informing the hiring unit of their status.