PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The University of Washington’s Human Subjects Division (HSD) within the Office of Research, has an outstanding opportunity for a full time IRB Reliance Administrator based at UW Tower.
The IRB Reliance Administrator is responsible for promoting and evaluating best practices and compliance for UW human subjects research. This includes management of regulatory relationships with non-UW IRBs as well as non-UW institutions and researchers who are participating in UW research; handling and coordination of inquiries, concerns, and complaints about UW human subjects research; and coordination with some non-IRB regulatory requirements such as clinical trials registration and financial conflict of interest review. This position is primarily responsible for establishing and managing regulatory relationships with non-UW IRBs around the world who will review UW research as well as with non-UW institutions and individuals (participating in UW research) for whom the UW IRB will provide regulatory review and oversight.
The IRB Reliance Administrator must understand many complex regulatory and ethical issues and how they apply to UW research. The position requires balancing the need to assure the UW’s compliance with state laws and several different sets of federal regulations with the need to facilitate research and with ethical considerations. This requires high-quality independent conceptual thinking that is aligned with the general perspective of HSD, analysis, and problem-solving. Daily work involves making judgment calls in ambiguous situations and applying a multi-faceted understanding of the concepts of “risk” and “engagement”. Daily contacts with researchers require diplomatic, professional and timely interactions based on concise, accurate, and intelligible communication that must usually be documented in writing. Almost all responsibilities require extensive reading. The IRB review process and reliance agreement process use an electronic web-based system, which requires individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between screens to obtain and synthesize information.
Review and approve reliance requests for non-UW IRB review of UW research (instead of the UW IRB). The review requires evaluation of requests against established criteria and may also involve drafting agreements using established templates, reviewing other non-UW institutional templates to ensure HSD-required elements are present, and communicating with non-UW IRB staff, researchers and other administrative offices to negotiate any changes. Coordinate these agreements with other compliance and regulatory requirements. Provide UW local context to other IRBs. Document outcomes and communicate decisions to researchers. Some of these agreements involve HSD joining a large consortium or network of institutions that all rely upon the same single IRB through a contractual agreement that requires consultation with the UW Attorney General’s office. May require coordination with other UW (e.g. Office of Sponsored Programs, Radiation Safety) and non-UW offices (e.g. IRB, institutional offices) as appropriate. Ongoing management includes metrics, and management or triage of reports of research-related noncompliance, unanticipated problems, inquiries, and complaints.
Review and approve reliance requests for UW IRB review of research on behalf of non-UW institutions. The review requires evaluation of requests against established criteria, preparing some requests for formal approval by a member of HSD’s management team, and may also involve drafting agreements using established templates, reviewing other non-UW institutional templates to ensure HSD-required elements are present, and communicating with non-UW IRB staff, researchers and other administrative offices to negotiate any changes. Coordinate these agreements with other compliance and regulatory requirements. Obtain local context from relying institutions. Document outcomes and communicate decisions to HSD staff and researchers. May require coordination with other UW (e.g. Office of Sponsored Programs, Radiation Safety) and non-UW offices (e.g. IRB, institutional offices) as appropriate. Ongoing management includes metrics, and management or triage of reports of research-related noncompliance, unanticipated problems, inquiries, and complaints.
Make determinations that a proposed project is not human subjects research or is exempt. Using an expedited process, review and approve modifications to existing studies or the addition of relying institutions as part of the process for establishing a reliance.
Provide regulatory advice and consultation to IRB staff and researchers regarding HSD’s policies for reliances and single IRB review, UW’s established broad institutional agreements for ceding IRB review and study-specific reliance agreements.
As part of process improvement activities, identify, plan, manage, and implement changes to policies, procedures, instructions, guidance, forms and templates.
Provide cross-team support for other team functions as needed.
Other duties as assigned by the Assistant Director for Reliances or the HSD Director.
Bachelor’s degree in a field that requires scholarly research. An advanced degree is preferred.
A minimum of 5 years of progressively responsible experience in human subjects research administration, or other field requiring familiarity with research methodologies. A detailed knowledge and understanding of the implementation of a complex regulatory system is required.
Demonstrated interpersonal and communications skills (both written and oral) are required, particularly the ability to write and speak in a concise, accurate, and intelligible manner.
Demonstrated ability to work both independently with minimal supervision and as part of a team with academic researchers and others.
Computer proficiency is required, including MS Word, Excel, internet browsers, and email. Almost all duties require extensive reading. Almost all processes are conducted via an electronic web-based system, which will require individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between screens to obtain and synthesize information.
Demonstrated experience at managing, tracking, organizing, prioritizing and documenting large volumes of complex tasks and information.
Demonstrated experience at working collaboratively with others to find creative solutions to problems.
Demonstrated experience involving outstanding attention to detail.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
A Master’s Degree in a field that requires scholarly research.
Experience in higher education is preferred; familiarity with a complex large research university is preferred, and/or experience in a higher education medical center.
Experience with IRB Reliances.
Familiarity with the research funding process and other research regulatory oversight mechanisms.
Professional IRB Certification (CIP).
Internal Number: 173546
About University of Washington
As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.
UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years.