Amendment Operations Lead

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 Amendment Operations Lead will oversee centralized clinical trial amendments in Clinical Research Support. The incumbent will be responsible for assessing and determining operational logistics of non-industry and industry-sponsored oncology clinical trial amendments, evaluating impacts, and determining necessary workflows. The incumbent works under minimal supervision in operational matters and reports to supervisor for process direction.

This position will support hiring and training of CRS Amendments Team members to central office standard practices, budget negotiations and clinic implementation in support of larger CRS strategic goals initiatives. This position will work with internal and external regulatory and fiscal specialists, to oversee and manage the central amendment workflow.

This position will develop and continue to refine best practices for a centralized amendment model. This position will be a subject matter expert for 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.

Responsibilities

• 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 throughout the study startup lifecycle to ensure adherence to timeline goals.
• Project manage and oversee standardization of amendment services to support fully centralized amendment services from triage to completion.
• Lead amendment team members facilitating 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.
• Lead and optimize amendment processes; determine and improve operational process standards based on feedback and data from internal and external partners.
• 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.
• 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 communications and trackers to maximize transparency and efficiency from triage to contract execution.
• Report amendment progress to Investigators, study teams, internal and external stakeholders to ensure transparency throughout the amendment p