Clinical Trial Amendments Manager

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 Clinical Trial Amendments Manager position will manage centralized clinical trial amendments in the Clinical Research Support department. The incumbent will be responsible for overseeing a team that will evaluate amendment impacts, determine and execute necessary workflows. This position will work directly with internal regulatory, clinic implementation, nursing and post award teams, study teams, central offices, clinic partners, faculty members and research collaborators to manage amendments. This position will oversee the team that manages updates to study calendar, billing grid, budgets, contracts and will coordinate with staff who manage orders updates. 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.

Oversee 4-8 Amendments specialists who will be responsible for the amendments workflow from triage to completion
• Oversee standardization of amendment services to support fully centralized amendment services from assignment to completion.
• Manage amendment timeline for the central amendments portfolio, ensuring that all triage, financial, clinic implementation and contract requirements are executed accurately and expeditiously.
• Engage with stakeholders - clinical trial office, clinical research operations specialists, clinical trial nurses, regulatory and contracting entities to ensure adherence to timeline goals and continuous process improvement
• Devise mitigation plans for high priority amendments that require expedited processing
• 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 process stakeholders
• Oversee the creation of 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.

MINIMUM QUALIFICATIONS:

• Bachelor's Degree or equivalent experience
• 4 years experience in clinical research operations
• Experience managing oncology clinical trials startup and/or amendment processes including calendar, billing grid reviews and budget development & negotiation
• 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 teamsForecasting and meeting deadlines
• 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

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 $97,552 to $154,148, 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).