Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The CTMS Program Office is a tri-institutional office housed within the Fred Hutch Research Administration department providing implementation and operational support services for the OnCore Clinical Trial Management System (CTMS) that is jointly managed by the Fred Hutch, the University of Washington and the Seattle Cancer Care Alliance.
The CTMS Functional Analyst position involves analyzing clinical research administration workflows across the institutions; mapping workflows to CTMS capabilities; designing and developing CTMS workflows, functional testing strategies and plans, and documentation. The role may lead several analysts and Subject Matter Experts (SMEs) to solve complex business, systems or adoption issues.
Partner with SMEs across study teams and administrative offices to understand workflow requirements related to clinical trial management workflows, such as calendar building, coverage analysis, budget management, subject visit tracking, sponsor invoicing, protocol management and subject management, and translate them into functionality that can be enabled via the CTMS system
Work with SMEs and analysts in related systems such as the Epic EHR system to functionally define, test and implement data flows from the CTMS into Epic
Deeply immerse and understand the capabilities of a CTMS, specifically OnCore from Forte Systems, to enable efficient workflows for research study teams and administrative offices
Effectively prepare for and facilitate design meetings and presentations with a diverse range of stakeholders including study coordinators, regulatory coordinators, fiscal coordinators, administrative offices staff and leadership
Develop functional testing scenarios and write detailed step-by-step scripts to enable functional testing
Partner with data migration team to define backload strategies that align with future state function workflows
Define and implement plans for pre-go-live data validation of migrated data with study teams and parallel offices
Provide clear and concise information to the training team and change management teams to support the development and delivery of training and adoption sessions
Create User Acceptance testing strategies, scenarios and scripts, and work side-by-side with users to conduct acceptance testing
Design highly accurate and comprehensive functional cutover plans, conduct go-live dress rehearsals and perform cutover activities
Provide go-live support to end users, and effectively transition functionality from implementation to operations
Minimum five (5) years of experience in clinical research operations
Experience working with CTMS systems; preferably OnCore
Experience with IRB systems and workflows is desirable
Experience with study financial management including calendar building, coverage analysis, budget management and sponsor invoicing
Experience working with CTMS integrations related to the Epic EHR system
Knowledge of applicable industry standards and best practices for clinical research
Advanced knowledge of business analysis tools, methodologies and best practices; including but not limited to leading cross-functional team discovery and business requirement sessions, process mapping and SWOT analysis
Experience with system conversion, customization and integration design and execution
Proven ability to communicate complex workflow issues to administrative offices and study team staff
Sustained, proven ability to think analytically, problem solve and use independent judgment
Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills
Superior presentation and organizational skills with an attention to detail mindset
Proven ability to work with a diverse group of stakeholders, including technical and non-technical personnel at various levels in the organization
Proven ability to teach and train others
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.