COMPLIANCE ANALYST
University of Washington Bothell
COMPLIANCE ANALYST | ||||||||||||||||||||||||||
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As a University of Washington (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. The oversight of human subjects research and protection of research participants is strongest and most successful when performed in an open culture and framework that values and embodies diversity, equity, and inclusion. The Human Subjects Division (HSD) expects its leaders, supervisors, staff, and Institutional Review Board members to be guided by this fundamental principle. The HSD community flourishes when a diverse group of people from all backgrounds, ethnicities, and identities work together to fulfill its mission. The HSD has an outstanding opportunity for Compliance Analyst to join their team. 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. 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 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. 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 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, 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 HSD’s policies for reliance agreements and single IRB review, UW’s 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 Assistant Director for Reliances or the HSD Director. REQUIREMENTS • Bachelor’s degree in the sciences, healthcare, communications, or arts & sciences; OR in a scientific/scholarly research field. • 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). 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. Application Process:The application process 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. | ||||||||||||||||||||||||||
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming. The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. 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. | ||||||||||||||||||||||||||
Open to Department employees only If you are a UW employee and would like to be considered for this position, please login to your UW employee profile to apply. |