Reliance Administrator

Job Description

Position Purpose

The Reliance Administrator works under the general direction of the Reliance Team Lead Operations (R-TOL) to support the review of multi-site and collaborative research trials where the UW is serving as the reviewing IRB.

Position Complexities

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 UWs 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 contact with researchers requires 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 multiple screens to obtain and synthesize information.

Position Dimensions and Impact to the University

HSD is a service and compliance unit within the Office of Research. It reports directly to the Assistant Vice Provost for Research Integrity. HSD and the IRBs it manages perform the federally required confidential institutional management and review of research activities involving human subjects that are conducted by UW faculty staff and students as well as researchers from a few other local or affiliated institutions. There are about 9500 human research studies at the UW. The research is remarkably diverse. It is distributed across almost every department and academic unit including the Bothell and Tacoma campuses. It may occur anywhere in the world; a significant percentage of UW research occurs outside of the U.S. The ability of the University to receive grants and to conduct human research depends upon ensuring compliance with federal and state regulations.

The IRB Reliance Administrator is responsible for adhering to and promoting 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; 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 across the United States 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.

DUTIES AND RESPONSIBILITIES

• (30%) 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. May require coordination with other UW (e.g. Office of Sponsored Programs Clinical Trials Office) and non-UW offices (e.g. IRB institutional offices) as appropriate. Ongoing management includes reviewing proposed changes to the research assisting researchers with meeting the terms of the reliance and management or triage of reports of research-related noncompliance unanticipated problems inquiries and complaints.

• (30%) 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 HSDs 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 Clinical Trials Office) and non-UW offices (e.g. IRB institutional offices) as appropriate.

• (20%) Perform initial and continuing IRB review of multi-institutional research. Includes using an expedited process to review and approve modifications to existing studies or the addition of relying institutions as part of the process for establishing a reliance.

• (10%) Provide regulatory advice and consultation to IRB staff and researchers regarding HSDs policies for reliance agreements and single IRB review UWs established broad institutional agreements for ceding IRB review and study-specific reliance agreements.

• (5%) Make determinations that a proposed project is not human subjects research or is exempt.

• (2%) As part of process improvement activities identify plan manage and implement changes to policies procedures instructions guidance forms and templates.

• (2%) Provide cross-team support for other team functions as needed.

• (1%) Other duties as assigned by the Associate Director for Reliances or the HSD Director.

REQUIREMENTS

• Bachelors degree in the sciences healthcare communications or arts & sciences.

• Minimum 4 years relevant applicable work or education experience which may include:

  • Human subjects research review/oversight;

  • Interaction with human subjects as a research staff person;

  • Any position involving the application of complex regulatory systems to individuals and work activities;

  • Experience with research ethics and methodologies.

Equivalent education/experience will substitute for all minimum qualifications.

Almost all duties require extensive reading/viewing of content on multiple screens.

The qualities of the successful candidate will include most or all of the following: (1) comfort with making judgment calls in ambiguous situations; (2) highly organized at tracking and prioritizing work; (3) outstanding attention to detail; (4) ability to write and speak in concise accurate and intelligible manner; (5) ability to work independently with minimal supervision; (6) analytical and problem-solving skills; (7) diplomatic and professional interpersonal skills; (8) ability to work well as part of a team; (9) computer proficiency including MS Word Excel internet browsers and email.

DESIRED QUALIFICATIONS

• Experience working in a higher education setting.

• Experience with IRB Reliance Agreements or single IRB review.

• Familiarity with the research funding process and other research regulatory oversight mechanisms.

• Professional IRB Certification (CIP).

Application Process: A cover letter is required for this recruitment. Your application will not be considered unless you attach a cover your cover letter please share more about your background and skills that are most relevant to this position.

Working Environmental Conditions

• Individuals may work at the HSD office on the UW Seattle campus 100% remote or a combination (hybrid). The HSD office is a standard open-plan office environment located in the UW Tower a high-rise office building on the edge of the UW Seattle campus.

• Work schedule and location flexibility is available and encouraged within the boundaries of HSD policy.

• Individuals must provide their own transportation to/from their official residence and their official duty station(s). The UW does provide:

  • Frequent free UW shuttles to some (but not all) Seattle locations.

  • Free U-PASS that gives an employee unlimited rides on Western WA regional buses commuter trains light rail and water taxis as well as full fare coverage on vanpools.

• The UW does not provide employees with free parking; parking is available at the UW Tower for a fee.

Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.