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- Provides overall leadership, planning, direction, organization, and program evaluation for the UH Human Studies Program in order to foster ethical research and protect UH from unnecessary compliance risk and reputational harm.
- Serves as foremost subject matter expert and recognized authority for the UH on federal regulations and UH policies and procedures that govern the protection of human subjects.
- Represents UH at community Institutional Review Boards (IRB), collaborating with their leadership to harmonize IRB processes in order to reduce redundancy and foster interdisciplinary multi-site clinical and translational research.
- Collaborates with administrative, academic and compliance leaders across UH to develop an integrated research compliance program.
- Exercises seasoned expert judgment while providing senior UH executives, administrators, and faculty with information, consultation and guidance on compliance with applicable regulations and policies.
- Provides technical and administrative supervision to subordinate staff of professionals, including subject matter experts and/or supervisors and/or technical and clerical personnel.
- Formulates and executes UH policies and procedures, seeking approval, as necessary, from the Vice President for Research and Innovation, Federalwide Assurance (FWA) Official, or other UH offices or officials.
- Ensures UH compliance with requirements of the DHHS Office of Human Research Protections (OHRP) by assuring that a current FWA is in place, cooperative IRB agreements are documented and registered with OHRP, and other OHRP and FDA requirements are met.
- Keeps abreast of and interprets changes and developments in pertinent regulations, policies, and industry standards and determines whether and how to effectively implement them at UH.
- Keeps abreast of and informs and updates the Vice President for Research and Innovation or delegated Institutional Official, HSP IRB committees and human studies research community, of the status and changes (con't.)
- (con't.) affecting accreditation with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
- Implements systems, procedures, software and other tools in collaboration with other UH programs to ensure coordinated and efficient compliance review and oversight of research across the UH system.
- Recruits individuals to serve as Human Studies Program (HSP) chairs and members, and represents UH to ensure compliance with federal regulations, including those designed to ensure consideration of local context and community values.
- Collaborates effectively with HSP chairs and members to manage potential conflicts of interest and to ensure an efficient and effective review process that complies with applicable regulations, policies and procedures.
- Designs and performs quality and compliance assessment activities, interpreting and reporting on results to UH leadership.
- Establishes and maintains a comprehensive training program for multiple audiences, including HSP chairs, members, staff, investigators, and others throughout the UH research community.
- Resolves complaints effectively and oversees investigations into allegations of non-compliance, ensuring that appropriate solutions and/or sanctions are appropriately determined and effectively implemented.
- Develops an annual budget for the UH Human Research Protection Program to be approved by the Vice President for Research and Innovation, and manages expenditures to ensure they do not exceed approved resources.
- Conducts, at a minimum, annual performance evaluations for subordinate staff of professionals, incl. subject matter experts &/or supervisors &/or technical & clerical personnel, & establishes reasonable measurable program objectives for staff to achieve.
- Represents UH at professional conferences and meetings and with state and federal regulatory agencies, providing appropriate information, and coordinating evaluation and/or auditing activities.
- Other duties as assigned
- Possession of a baccalaureate degree in biomedical or behavioral science, biology, public health, nursing or related field and 7 years of progressively responsible professional experience with responsibilities for human subjects of which one year shall have been at the supervisory level; or equivalent education/training or experience.
- Extensive knowledge of innovative and state-of-the-art principles, concepts and principles, emerging theories, the current federal and state laws and associated rules, regulations and interpretations and systems associated with the protection of research subjects.
- Demonstrated ability to develop short- and long-term plans of actions, understand problems from a broad perspective, use unconventional reasoning to discern broad underlying principles and issues when problem solving.
- Demonstrated written and verbal mastery in presenting ideas, theories, issues and models clearly and accurately using persuasion and negotiation to build consensus and cooperation and provide long-term direction and leadership.
- Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups 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 develop short- and long-term plans of actions, understand problems from a broad perspective and use conventional and unconventional reasoning to discern underlying principles and issues to create innovative solutions.
- Any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated.
- Experience in providing leadership to human research protection program.
- Demonstrated ability to establish and implement a comprehensive educational program in human studies compliance.
- Master's degree in biomedical or behavioral science, biology, public health, nursing or related field.
- Experience and/or knowledge in the UH and Research Corporation of the University of Hawaii (RCUH) system.
- Knowledge of or familar with the Institutional Review Board.
- Participation in the performance of human subjects research.
- Experience with related compliance areas such as conflicts of interest, scientific integrity, good clinical practice, privacy and confidentiality, etc.
- OVPRI Human Resources; 808-956-8166; email@example.com
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.