Clinical Trial Startup Operations Manager – Non-Industry

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. 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.

We are actively expanding our central research teams to support Principal Investigators (PIs) and study teams who are focused on mission-critical clinical trials programs. The Clinical Trial Startup Operations Manager – Non-Industry will support centralized clinical trial start-up for non-industry studies. Non industry clinical trials include studies sponsored by investigators, foundations, federal agencies, and other non-industry entities.

The incumbent will be responsible for assessing new non-industry oncology clinical trials, creating and managing startup plans, reviewing requirements and timelines. This position will manage Budget Specialists relative to centralized study startup standard practices and actively partner with clinic implementation, regulatory and other functions. This position will develop and continue to refine best practices for a centralized non-industry study startup model. This position will be a subject matter expert for research processes, non-industry-sponsored oncology clinical trials, and maintain institutional knowledge of startup requirements, dependencies, site-specific clinic implementation, pre and post-award requirements.

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

• Prioritize and proactively implement standardization of startup services to support non-industry clinical trials.
• Oversee Budget Specialists facilitating centralized non-industry startup activities on behalf of study teams.
• Closely partner with protocol writing services & database management services for Investigator Initiated Trials (IITs) to help ensure operational and financial feasibility considerations are addressed during the protocol development process.
• Manage and oversee operations to ensure continuity with central startup metric goals, best practices and standards in support of larger Clinical Research Support strategic initiatives to reduce startup times.
• Review and assess new clinical trial documents to identify and anticipate operational and resource requirements.
• Serve as subject matter expert in identifying research costs, reviewing study calendars & billing grids, developing and negotiating budgets, coordinating contracting processes in accordance with w/protocol and institutional requirements.
• Manage and oversee the preparation and submissions of new non-industry clinical trials to internal financial, regulatory and clinical offices.
• Initiate and facilitate meetings with investigators, study teams and central office partners in support of centralization, timeline reduction, workflow and process improvement goals.
• Provide management and oversight of central team source documentation maintenance and record keeping practices throughout the startup process; ensure continuity with CRS standards and best practices for optimal transparency.
• Oversee and optimize weekly startup progress reporting to Investigators, study teams, internal and external stakeholders to ensure transparency and accurate expectations throughout the startup process.
• Work closely with Consortium members and study teams to support comprehensive non-industry study startup plan, goals and deadlines.
• Work professionally and proactively with central offices, clinic partners, faculty m