Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.

The Institutional Review Office (IRO) functions as the central office for managing the ethical review and approval of human or animal studies conducted at Fred Hutch, with specific responsibilities for supporting the Institutional Review Boards (IRBs) and the Institutional Animal Care and Use Committee (IACUC).

The IRO IT Business Analyst II is responsible for providing subject matter expertise and oversight in the implementation and support of the IRB and IACUC solutions in the Huron Research Suite.

Responsibilities

Implement and support the IRO electronic systems

• Discover and document functional requirements for system implementation, upgrades, and integrations
• Configure systems for optimal process flows and efficient user interface
• Use appropriate tools to achieve project deliverables
• Support system and/or process change with proper planning, timely execution, user training, and issue tracking and resolution
• Design, manage, and participate in user testing, and solicit user feedback for integration into systems
• Track and propose post-implementation enhancement requests and work with applicable stakeholders to determine impact, urgency, and value
• Develop, update, and/or review system user documentation of functional design changes and ensure usefulness with training resources in support of Fred Hutch training efforts
• Provide coverage for IRO Support functions including inbox monitoring and triage, system maintenance tasks, user access, and issue problem-solving

Collaborate with teams to deliver on project objectives

• Assist the Senior Business Analyst and applicable project resources, including project manager(s), to ensure successful project objectives, timelines, documentation, and deliverables
• Work with subject matter experts to gather functional requirements and create use cases according to project standards
• Effectively communicate IRO business needs to IT project teams, and consult with IRO staff to support IT projects
• Solve cross-functional design issues in cooperation with developers
• Identify and troubleshoot system bugs with software vendor
• Cultivate effective relationships within the IRO, Center IT, IRB and IACUC committees, and across campus to support trust, consistency, and competence of the team

Optimize IRO business processes

• Discover, evaluate, optimize, and document business processes
• Define workflow/routing within the IRO, identify gaps in process, and work with IRO leadership to successfully alter processes as needed
• Collect and analyze data to inform decisions
• Assist the Senior Business Analyst to gather data and produce reports and metrics as requested

Perform policy analysis and assist the IRO in regulatory compliance

• Analyze new policy considerations and provide strong, coherent input to key stakeholders for establishing Center policy
• Aid IRO leadership in decision-making by providing sound judgment and transparent analysis
• Collaborate with other Fred Hutch departments to develop Center policies
• Create decision documents as a framework for documenting policy options
• Understand IRB and IACUC review systems and technical issues and facilitate problem-solving and resolution within and across these modalities
• Ensure system designs support compliance with regulations, laws, rules and policies that impact the review of research overseen by the IRO

Required

• Bachelor’s Degree in Information Technology, Computer Science, or other related field.
• Minimum 5 years of IT business analysis experience managing Enterprise applications.
• Experience with application development lifecycle methodology as well as IT analysis mythologies such as process flow definition, data flow diagramming etc.

Preferred

• 2 years of experience supporting business applications in a research or non-profit setting
• Experience in designing and leading requirements discovery sessions including use of interviews, document analysis, surveys, business process modeling, and workflow analysis
• Exceptional analytical and conceptual thinking skills
• Advanced technical skills
• Excellent planning, organizational, and time management skills
• Strong communications and customer service skills
• Knowledge of research-related policies and regulations, including FDA 21 CFR Part 11 preferred
• Experience in the applications that support IRB and IACUC Management preferred; including the IRB and IACUC solutions in the Huron Research Suite
• Familiarity with SQL preferred
• Certified IRB Professional (CIP) preferred