Amendments Operations and Budget Specialist

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. 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.

This position will manage workflows and financials for Oncology clinical trial amendments across sponsor types (Industry, IIT). The incumbent will be responsible for assessing oncology clinical trial amendments, evaluating impacts including financial impacts, and determining necessary workflows. This position will work directly with internal operations, nursing, regulatory and post award teams, study teams, central offices, faculty members, and research collaborators to manage amendments.

This position requires understanding of research processes, non-industry, and industry-sponsored oncology clinical trials, and maintain institutional knowledge of amendment requirements, dependencies, billing grid, budget, and post-award requirements.

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.

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.

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.
• 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.
• Create and amend comprehensive clinical trial budgets and manage budget negotiations with industry pharmaceutical sponsors on behalf of research groups in alignment with CRS standards.
• 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.)
• 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, internal operations, nursing, clinic partners, faculty members and research collaborators.
• 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 communications and project management tools 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 process in support of larger strategic initiatives.
• Support CRS initiatives that will enable study teams to maximize post award management and cost recovery.

MINIMUM QUALIFICATIONS:

• Minimum 3 years' experience coordinating industry-sponsored clinical trials, preferably oncology trials
• Bachelor's Degree or equivalent years of experience
• Demonstrated ability to deliver outcomes in fast-paced environments
• Demonstrated ability to work as an effective member of an interdisciplinary team
• Demonstrated skills in critical thinking and problem solving
• Ability to process complex documents and extract key information
• Working with multi-disciplinary teams
• Forecasting and meeting deadlines
• Communicating with all levels of a research organization
• Knowledge of clinical trial budgets
• Familiarity with project management tools and techniques
• Familiarity with CTMS and systems to support workflow & metrics
• Proficiency in use of Excel, MS Word, and Acrobat
• Strong verbal and written communication skills
• Strong attention to detail and ability to work according to CRS central office standards and best practices
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders
• Effectively able to communicate and demonstrate accountability in a remote setting

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred
• Demonstrated experience in clinical trial financials including budget development and negotiation
  
• Basic knowledge of Medicare Coverage Analysis
  

The annual base salary range for this position is from $77,976 to $109,470, and pay offered will be based on experience and qualifications.

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.

This position is not eligible for H1-B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).