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Office of Research has an outstanding opportunity for the Director, Human Subjects Division. This recruitment is open to University of Washington employees only.
The Director is the leader of the University of Washington’s (UW) Human Subjects Division (HSD), which is part of the UW’s Office of Research. HSD provides expert, efficient, and innovative leadership and guidance for fulfilling UW responsibilities associated with human subjects research. HSD is responsible for the federally required ethical and regulatory review and oversight of about 6500 active human studies conducted by UW faculty, staff, and students and some other institutions. The purpose of the reviews and oversight is to protect the safety, rights, and welfare of research participants and to ensure institutional compliance with multiple sets of federal regulations, state laws, and UW policies. The reviews are conducted by the UW’s four Institutional Review Boards (IRBs) comprising approximately 70 members, or by numerous external (i.e., non-UW) IRBs with whom HSD establishes legally binding reliance agreements. The UW IRBs also serve as the Single IRB for UW-led research that involves multiple institutions, which may be located anywhere in the United States. In addition, HSD is responsible for the management and continued improvement of a complex web-based IRB application and review system (Huron’s Click IRB), with an attendant rich menu of metrics and reporting capabilities; a robust post-approval monitoring program; management of noncompliance, complaints, and inquiries; and use of current-state technology HSD has policy making authority, working with the Office of Research, and routinely provides guidance to researchers about regulatory and ethical issues.
The Director has primary responsibility for an annual operating budget of about $4.8 million and for the management and professional development of about 40 professional and administrative staff, as well as the four IRBs, formal and informal relationships with many other U.S. IRBs, and all programs and systems managed by HSD. Another primary responsibility is to work with researchers, other UW compliance offices, and senior and academic leadership to solve complex problems and to provide guidance and information. The HSD Director is expected to actively initiate and continually refine collaborative long-term and short-term strategic visioning and planning, as well as to engage in policy-making.
RESPONSIBILITIES:
Review and oversight of research
Provide high-level support to the IRBs, including ensuring adequate membership and expertise on the UW IRBs and robust opportunities for the IRBs to obtain expert consultation. Continue development and refinement of supporting policies, SOPs, guidance, and work tools with content that is consistent, up-to-date, easily accessed, and searchable, and grounded on evidence-based ethics and practices. Oversee the operation and continued development of a post-approval research monitoring program. Ensure appropriate handling of sensitive noncompliance, unanticipated problems, inquiries and complaints. Direct the continued development and utilization of a substantial internal quality assurance program (HSD staff; IRB reviews). Oversee and, as needed, participate in, the negotiation of new and revised reliance agreements.
Consultation, Guidance, Interpretation
Provide consultation and guidance to HSD staff, IRB members, UW leadership, researchers, other UW compliance offices, affiliated institutions, and cooperative partner institutions on: interpretation and administration of regulations and HSD policies; complicated or multiple-issue projects; new and emerging research areas with complex ethical issues; and best practices. Includes development and revision of policies, procedures, guidance, and best practices for a variety of audiences, including learners. Consult with UW Division of WA State Attorney General’s office, federal agencies, and other UW compliance offices.
Strategic Planning and Initiatives
Establish and pursue strategic vision and goals, identify and prioritize supporting initiatives, develop or oversee short-term and long-term planning. Assist senior UW research leadership in developing research administration strategic plans and subsequent goals. Draw upon HSD metrics and wide-ranging knowledge of nationally evolving best practices and current and anticipated regulatory developments. Evaluate outcomes and identify appropriate refinements.
Liaison and Representation
Other UW compliance offices and other regional IRB offices: Serve as the primary liaison to most of these offices. Typically includes membership on committees and workgroups. Work together to identify and pursue mutually beneficial initiatives and address complex problems. Provide requested information, including in response to records subpoenas and public records requests. Federal agencies, research sponsors, auditors, other institutions; Represent UW and/or HSD; oversee and ensure required reporting; provide information and respond to requests. Media: Respond to media requests, often in coordination with other UW offices or entities.
Office Management
Finances: Develop, monitor, and manage annual budget of $4.8 million, including projections and ensuring fiscal accountability. Make spending and re-allocation decisions. Seek additional funding as needed. Personnel: Oversee hiring, employee management, and performance evaluations. Revise organizational structure as needed. Encourage staff retention and professional development. Foster a sense of community and collaboration among HSD staff. Facilities: Oversee allocation of space and resources. Maximize use/setup as needs and circumstances change.
Communication
Manage and develop effective, predictable and searchable means of communicating (changes, new information, policies, guidance, events) with HSD staff, IRB members, researchers and other UW compliance offices.
Other duties as required
Supervisory Responsibilities
The Director provides direct supervision of the four members of the HSD Management Team as well as four of the five members of the HSD Project Team.
REQUIREMENTS:
Bachelor’s degree in any research-oriented discipline or profession
Minimum of seven years of progressively responsible experience in human subjects research administration, including experience directly related to IRB administration and operations and research compliance, preferably in an academic or health sciences setting
Extensive knowledge of current federal regulations, state laws, and University policies related to human subjects research
Working knowledge of a significant body of scientific and medical concepts and terminology
Strong leadership and management experience, including direct oversight and responsibility for staff, hiring and performance management, and engaging, inspiring, and developing staff at all levels
Strong teamwork/collaborative experience in work or non-work setting with building or enhancing high-performing, cohesive, and inclusive teams for ongoing and/or project work
Demonstrated ability at effective spoken and written communication with individuals at all levels and all levels of knowledge
Demonstrated ability to facilitate learning, including curriculum development and delivery, as appropriate to a wide variety of learners
Deep understanding of change management issues and principles
Experience at making and communicating hard decisions with diplomacy
Mental flexibility and creativity while addressing complex, ambiguous situations, including recognition of when it is appropriate to make decisions with incomplete information
CONDITIONS OF EMPLOYMENT:
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.
