Amendments Operations and Budget Specialist

$69,472 - $104,187/Yr

Fred Hutchinson Cancer Center - Seattle, WA

Full-time - Mid Level

Seattle, WA

About the position

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.

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 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.).
• 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 process in support of larger strategic initiatives.
• Support CRS initiatives that will enable study teams to maximize post award management and cost recovery.

Requirements

• Minimum 3 to 5 years' experience coordinating 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.

Nice-to-haves

• Clinical research related certification.
• 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.

Benefits

• Medical/Vision insurance
• Dental insurance
• Flexible spending accounts
• Life insurance
• Disability insurance
• Retirement plans
• 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)
• Partially paid sabbatical leave (up to 6 months)