Amendments Operations and Budget Specialist

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. 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 to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Amendments Operations and Budget Specialist will manage industry centralized clinical trial amendments in the Clinical Research Support. The incumbent will be responsible for assessing the operational logistics of non-industry and industry-sponsored oncology clinical trial amendments, evaluating impacts, and determining necessary workflows. This position will work directly with internal regulatory and post award teams, study teams, central offices, clinic partners, faculty members and research collaborators to manage amendments.

 

This position will manage centralized clinical trial amendments and budget negotiation in support of larger CRS strategic goals initiatives. This position requires understanding of research processes, non-industry, and industry-sponsored oncology clinical trials, and maintain institutional knowledge of amendment requirements, dependencies, site-specific clinic implementation, and post-award requirements.

 

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

 

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

PRIMARY/ESSENTIAL DUTIES:

• Manage amendment timeline, ensuring that all financial, clinic implementation and contract requirements are executed accurately and expeditiously. Engage clinical trial office, clinic, regulatory and contracting entities to ensure adherence to timeline goals.
• Project manage and oversee standardization of amendment services to support fully centralized amendment services from assignment to completion.
• Manage centralized amendment processing activities on behalf of study teams to ensure continuity with institutional goals, best practices, and standards in support of larger CRS strategic initiatives to increase quality, compliance and reduce amendment processing times.
• Improve operational process standards based on feedback and data from internal and external partners to optimize amendment processes.
• Ensure all amendment impacts clinical and financial are integrated by working proactively with central offices, clinic partners, faculty members and research collaborators.
• Create comprehensive budgets and ensure clinical trial budgets support protocol amendment implementation, and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team time and effort, etc.).
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• Serve as a subject matter expert in clinical trial amendment operationalization, financial evaluation, and resource allocation.
• Collaborate with pharmaceutical sponsors, institutional sponsors, and study teams to integrate and implement protocol amendment requirements.
• Manage source documentation and records practices throughout the amendment process for continuity with CRS standards and best practices.
• Manage commu