Senior Director, Clinical Trial Startup & Amendments

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 CRS Senior Director, Clinical Trial Startup & Amendments, will provide senior operational leadership for clinical trial startup and amendments implemented at the main campus and Fred Hutch Community Sites.  The role is a key leadership position within Clinical Research Support, the central clinical trials office at Fred Hutch that serves Fred Hutch and the UW/Fred Hutch/Seattle Children’s Cancer Consortium and oversees 4+ teams composed of 40+ FTEs in a rapidly growing area of the operation. The incumbent reports to the AVP, Clinical Trial Startup, Financial Management & Strategic Initiatives. The individual who holds this role exemplifies the Fred Hutch mission, vision and values and acts to support & enhance every aspect of our clinical research support activities.

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

• Define direction and enhance workflows to deliver integrated startup services & implementation of post startup amendments for oncology trials that include investigator-initiated, and industry sponsored trials conducted at the main campus and the Fred Hutch Community Sites.
  • Expand current central startup services to include structured project management of early feasibility, site qualification processes, and research group reviews, prior to studies formally entering the startup pipeline.
  • Integrate study financial/regulatory startup activities with clinic implementation activities including orders development and implement end-to-end project management of study startup.
  • Scale the central startup team to support higher volumes.
  • Drive continuous process improvement to maintain startup timelines of less than 100 days for intake to open to accrual.
  • Expand post start-up amendments service.
  • Integrate study financial/regulatory management for amendments with clinical implementation & orders management.
  • Drive continuous process improvement to maintain amendments implementation timelines as necessitated by subject activity on trials.
  • Partner with CRS finance and drive continuous process improvement to maintain a complete feedback loop from post award activity into study startup & amendments workflows.
• Define and maintain quality, performance, and utilization metrics; report key measures to leadership identifying risk, and opportunities for growth and improvements.
• Integrate key workflow improvement technologies such as REDCap, Zendesk, Smart Sheet and OnCore CTMS into team workflows.
• Help implement key model improvements over the next 1-3 years such as enhanced approaches for MCA development, coding, pricing, and contracts for the Oncology study portfolio.
• Build and maintain flexible staffing model, be able to determine metric driven staffing levels, select, develop, and evaluate personnel to ensure efficient and scalable operation to serve needs of expanding portfolio.
• Create, refine, and maintain operational policies, Standard Operating Procedures (SOPs), and qual