Research Manager, Startup Regulatory Operations

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.

The Startup Regulatory Operations Manager is responsible for overseeing and coordinating regulatory startup activities to support the timely activation of clinical research studies. This role serves as a key liaison among investigators, sponsors, research teams, institutional review boards (IRBs), regulatory agencies, ancillary departments, and institutional stakeholders to ensure regulatory compliance and operational readiness during study startup.

The position provides strategic and operational leadership for regulatory processes, including protocol review, regulatory submissions, study activation requirements, investigator and site documentation management, regulatory training compliance, and startup workflow optimization. The individual ensures adherence to federal regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and applicable research standards while supporting efficient study activation and enrollment timelines.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

This is a remote position.

Regulatory Startup & Study Activation:

• Lead regulatory startup and activation activities for a portfolio of industry-sponsored and investigator-initiated studies, coordinating required documentation, approvals, training, system access, and cross-functional startup activities.
• Monitor startup performance metrics, regulatory milestones, and activation timelines; identify risks and implement mitigation strategies to achieve departmental service-level expectations and accelerate study activation.

Regulatory Compliance & Quality Oversight:

• Ensure regulatory compliance through review and collection of protocols, informed consents, Investigator’s brochures, regulatory files, essential documents, investigator credentials, training records, and study documentation.
• Maintain inspection readiness and support audits, monitoring visits, quality assurance activities, and implementation of regulatory systems and document management processes.

Operational Excellence & Stakeholder Engagement:

• Develop and implement regulatory startup strategies, standardized processes, best practices, and continuous improvement initiatives to enhance efficiency and reduce activation timelines.
• Serve as the primary regulatory liaison for…