Fred Hutchinson Cancer Center - Seattle, WA
posted 2 months ago
The Amendments Operations and Budget Specialist at Fred Hutchinson Cancer Center plays a crucial role in managing industry centralized clinical trial amendments within the Clinical Research Support (CRS) team. This position is responsible for assessing the operational logistics of both non-industry and industry-sponsored oncology clinical trial amendments. The incumbent will evaluate the impacts of these amendments and determine the necessary workflows to ensure smooth operations. The role requires close collaboration with various stakeholders, including internal regulatory and post-award teams, study teams, central offices, clinic partners, faculty members, and research collaborators to effectively manage amendments. In addition to managing centralized clinical trial amendments, the specialist will also oversee budget negotiations that align with larger CRS strategic goals and initiatives. A deep understanding of research processes, particularly in the context of oncology clinical trials, is essential. The specialist will maintain institutional knowledge of amendment requirements, dependencies, site-specific clinic implementation, and post-award requirements. This position is integral to ensuring that all financial, clinic implementation, and contract requirements are executed accurately and expeditiously, thereby supporting the overall mission of Fred Hutch to discover new cures for the world's deadliest diseases. The role also involves project management responsibilities, including the standardization of amendment services from assignment to completion. The specialist will work to improve operational process standards based on feedback and data from internal and external partners, ensuring that all amendment impacts—both clinical and financial—are integrated effectively. This includes creating comprehensive budgets that support protocol amendment implementation and institutional requirements, such as institutional fees and study team time and effort. The Amendments Operations and Budget Specialist will also be responsible for reporting amendment progress to investigators and stakeholders, ensuring transparency throughout the amendment process in support of larger strategic initiatives.