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 Startup Operations and Budget Specialist will manage industry clinical trial startup in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new industry-sponsored clinical trials and creating start-up plans including review requirements and timelines. This position will work closely with internal and external regulatory and fiscal specialists to manage start-up tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met.

This position will manage centralized study start-up standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of the research process for industry-sponsored clinical trials, knowledge of start-up requirements, clinic implementation, and financial resources required to conduct clinical research.

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.

Responsibilities

PRIMARY/ESSENTIAL DUTIES:

• Project manage the study industry startup timeline and operations from assignment to activation on behalf of 11 research groups for Phase I-IV interventional treatment and device trials.
• Manage 15-week startup 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 metric timeline goals.
• Develop clinical trial budgets and manage budget negotiations with industry pharmaceutical sponsors on behalf of research groups in alignment CRS central startup standards in support of larger CRS strategic initiatives.
• Lead clinic implementation planning, operations, and logistics with internal and external stakeholders on behalf of research groups in support of larger CRS strategic initiatives.
• Create comprehensive budgets and ensure industry sponsored clinical trial budgets support protocol 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 startup operationalization, financial evaluation, and resource allocation.
• In collaboration with industry pharmaceutical sponsors and study teams lead the development and review of projected start-up timelines, milestones, and comprehensive integration of protocol requirements for study implementation.
• Manage source documentation and records throughout the startup process for continuity with CRS industry startup team standards and best practices.
• Manage communications and trackers to maximize transparency and efficiency from assignment to handoff.
• Ensure all protocol requirements can be met upon activation by working proactively with central offices, clinic partners, faculty members and research collaborators to.
• Report startup metrics to industry sponsors, Investigators, study teams and CRS leadership weekly to ensure transparency throughout the startup process in support of larger CRS strategic initiatives.
• Support CRS initiatives that will enable study teams to maximize post award management and cost recovery.

Qualifications

MINIMUM QUALIFICATIONS:

• Minimum 3-5 years' experience coordinating industry-sponsored clinical trials, or other equivalent experience.
• 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.
• Basic 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.
• Previous experience with oncology trials.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

The annual base salary range for this position is from $69,472 to $104,187, and pay offered will be based on experience and qualifications. 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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity