Risk Management Specialist (Compliance & Risk Manager - 0081143T)

University of Hawaii•Kaka'ako - Honolulu, HI

1d•Onsite

About The Position

Serve as the subject matter expert for and manager of day-to-day compliance and risk management matters for both the John A. Burns School of Medicine (JABSOM) and the UH Cancer Center (UHCC). Advise on a wide variety of human subjects research regulatory, compliance, and risk management matters, including the Health Insurance Portability and Accountability Act (HIPAA), Protected Health Information (PHI), Personally Identifiable Information (PII), UH-regulated data, and other related issues. Lead and conduct senior-level policy analysis of any new or revised regulatory requirements related to compliance and risk management; develop policies and procedures as needed to assure the adequacy of JABSOM and UHCC existing policies and systems. Develop and lead educational and training programs to promote faculty, staff, students, applicable contractors, researchers, and volunteers' knowledge of and compliance with pertinent laws, rules, policies, or best practices related to compliance, risk management, risk mitigation, and malpractice risk mitigation and management. Serve as JABSOM and UHCC HIPAA Privacy officer/unit coordinator, ensuring a timely and well-coordinated response to HIPAA privacy issues. Collaborates closely with the UHCC Human Subjects Compliance Officer and staff assigned to regulatory work to ensure similar, if not identical, processes and training where applicable. Manage and/or collaborate with institutional HIPAA privacy boards, including those of major academic-affiliated health systems that participate in clinical research with JABSOM and/or the UHCC. In collaboration with the Kakaako Campus Shared Administrative Services (KCCAS) HIPAA/Data Security officer and UH System's Office of Research Compliance, HIPAA Privacy, Data Security, and Data Governance Offices, assist in managing and expanding the visibility of the JABSOM and UHCC compliance program. Identify potential compliance vulnerabilities external to and within JABSOM and the UHCC and determine the level of risk; recommend to the KCCAS Oversight committee risk remediation, including an assessment of internal controls, as applicable. Develop and/or monitor the implementation of corrective action plans and/or process improvements resulting from internal or external reviews, and approved recommendations from regulatory agencies. This includes review of Reportable Protocol deviations and IRB replies or other actions required by reviewers. Coordinate and oversee regulatory submissions and reporting activities, including working with regulators and others to clarify and resolve issues. Frequently interact with the Office of General Counsel for assistance in the interpretation of regulatory requirements and/or legal advice on issues, concerns, or risks. Frequently interact with UH System Office of Research Services, Office of Research Compliance, Data Governance Office, and the Institutional Review Board to assist with regulatory matters in sponsored projects administration and the conduct and administration of clinical trials. Responsible for the coordination of clinical research compliance activities in conjunction with JABSOM's clinical and healthcare affiliates. Inform, advise, and recommend actions for the JABSOM after consulting and receiving approval from the JABSOM compliance committee that includes the JABSOM Dean, Associate Deans, Chief Financial Officer, and the Designated Institutional Official. Prepare quarterly reports for the compliance committee on the progress and status of projects, including anticipated issues, major policy changes, project implications related to HIPAA, PHI, medical malpractice, insurance risk, and other compliance matters. In close coordination with the unit- or Kakaako campus level grants administration office or program: Support and cooperate in all external audits performed by external sponsors and regulatory agencies. Facilitate review and execution of contracts for research Support compliance with administrative requirements for research grants Advise and provide administrative support to UHCC and JABSOM Data and Safety Monitoring Committee(s). Resolve administrative matters in accordance with current policies, procedures, directives, and past practices. Responsible for administering, monitoring, negotiating, recommending, and implementing JABSOM's and UHCC professional liability insurance program in collaboration with University Health Partners of Hawai'i. Initiates and is responsible for confidential and sensitive, as well as general written and oral communications, exercising tact, diplomacy, and good judgment in relation to others. Work as a team member to identify, coordinate, evaluate, and solve problem areas, including functions that are part of the Kaka’ako Campus Centralized Administrative Services. Supervise subordinate employees assigned to the respective unit. Other duties as assigned Denotes Essential Job Duties

Requirements

Possession of a baccalaureate degree in business administration, management, law/legal studies, healthcare administration/management, human health science (i.e., biology, psychology, neuroscience, human biology, nursing, pharmacy, etc.) or related field and 9 year(s) of progressively responsible professional experience with responsibilities for research, academic and/or clinical compliance matters; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.
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 and/or clinical compliance.
Comprehensive knowledge and understanding of a wide range of principles, theories, federal and state laws and systems associated with research, academic, and/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 innovative 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 and/or scope.
Demonstrated ability to direct, lead, assign, organize, set objectives, and 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, and evaluate the work of subordinate level professionals and estimate staffing needs and schedules, and assign work to meet deadlines and goals.
Knowledge of the principles, practices, and techniques of governmental practices and negotiations specific to public and/or private colleges and universities.
Expertise concerning federal and state laws and organizational policies regarding the maintenance of HIPAA and PHI related information.

Nice To Haves

Master's degree and 5 years of progressively responsible experience in the field of compliance and/or regulatory roles.
HIPAA Compliance Officer Training, Certification in Healthcare Research Compliance (CHRC) and/or Certified Healthcare Privacy Compliance (CHPC).
Clinical Research Associate (CRA) certification or training.
Current CITI Training in the Protection of Human Research Subjects.
Demonstrated ability to successfully establish, advocate, and adhere to policies, practices, procedures, and principles in the best interest of the organization despite strong opposing views and opinions.
Ability to exercise initiative by anticipating and proactively addressing compliance and operational issues or situations.
Demonstrated ability to use presentation software (i.e., Canva).
Experience in project management.

Responsibilities

Serve as the subject matter expert for and manager of day-to-day compliance and risk management matters for both the John A. Burns School of Medicine (JABSOM) and the UH Cancer Center (UHCC).
Advise on a wide variety of human subjects research regulatory, compliance, and risk management matters, including the Health Insurance Portability and Accountability Act (HIPAA), Protected Health Information (PHI), Personally Identifiable Information (PII), UH-regulated data, and other related issues.
Lead and conduct senior-level policy analysis of any new or revised regulatory requirements related to compliance and risk management; develop policies and procedures as needed to assure the adequacy of JABSOM and UHCC existing policies and systems.
Develop and lead educational and training programs to promote faculty, staff, students, applicable contractors, researchers, and volunteers' knowledge of and compliance with pertinent laws, rules, policies, or best practices related to compliance, risk management, risk mitigation, and malpractice risk mitigation and management.
Serve as JABSOM and UHCC HIPAA Privacy officer/unit coordinator, ensuring a timely and well-coordinated response to HIPAA privacy issues.
Collaborates closely with the UHCC Human Subjects Compliance Officer and staff assigned to regulatory work to ensure similar, if not identical, processes and training where applicable.
Manage and/or collaborate with institutional HIPAA privacy boards, including those of major academic-affiliated health systems that participate in clinical research with JABSOM and/or the UHCC.
In collaboration with the Kakaako Campus Shared Administrative Services (KCCAS) HIPAA/Data Security officer and UH System's Office of Research Compliance, HIPAA Privacy, Data Security, and Data Governance Offices, assist in managing and expanding the visibility of the JABSOM and UHCC compliance program.
Identify potential compliance vulnerabilities external to and within JABSOM and the UHCC and determine the level of risk; recommend to the KCCAS Oversight committee risk remediation, including an assessment of internal controls, as applicable.
Develop and/or monitor the implementation of corrective action plans and/or process improvements resulting from internal or external reviews, and approved recommendations from regulatory agencies.
Coordinate and oversee regulatory submissions and reporting activities, including working with regulators and others to clarify and resolve issues.
Frequently interact with the Office of General Counsel for assistance in the interpretation of regulatory requirements and/or legal advice on issues, concerns, or risks.
Frequently interact with UH System Office of Research Services, Office of Research Compliance, Data Governance Office, and the Institutional Review Board to assist with regulatory matters in sponsored projects administration and the conduct and administration of clinical trials.
Responsible for the coordination of clinical research compliance activities in conjunction with JABSOM's clinical and healthcare affiliates.
Inform, advise, and recommend actions for the JABSOM after consulting and receiving approval from the JABSOM compliance committee that includes the JABSOM Dean, Associate Deans, Chief Financial Officer, and the Designated Institutional Official.
Prepare quarterly reports for the compliance committee on the progress and status of projects, including anticipated issues, major policy changes, project implications related to HIPAA, PHI, medical malpractice, insurance risk, and other compliance matters.
Support and cooperate in all external audits performed by external sponsors and regulatory agencies.
Facilitate review and execution of contracts for research
Support compliance with administrative requirements for research grants
Advise and provide administrative support to UHCC and JABSOM Data and Safety Monitoring Committee(s).
Resolve administrative matters in accordance with current policies, procedures, directives, and past practices.
Responsible for administering, monitoring, negotiating, recommending, and implementing JABSOM's and UHCC professional liability insurance program in collaboration with University Health Partners of Hawai'i.
Initiates and is responsible for confidential and sensitive, as well as general written and oral communications, exercising tact, diplomacy, and good judgment in relation to others.
Work as a team member to identify, coordinate, evaluate, and solve problem areas, including functions that are part of the Kaka’ako Campus Centralized Administrative Services.
Supervise subordinate employees assigned to the respective unit.