CRS Clinical Trials Specimen Processing Manager

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.

 

The Clinical Trial Specimen Processing Manager is responsible for supporting oncology clinical trials conducted within the Fred Hutch, University of Washington, Seattle Children’s Cancer Consortium (Consortium). This is an upper-level management position within Clinical Research Support (CRS) overseeing a team of lab technicians and operations specialists performing specimen processing. The manager is a Subject Matter Expert and has mastery of all technical job requirements.  The role is responsible for managing trial participant’s central lab tests including but not limited to pharmacokinetics (PK), cytokines, peripheral blood monocytes (PBMC), RNA, DNA, hematology, and chemistry panels. This position oversees all aspects of a specimen processing lab that manages high volumes of clinical trial specimens for complex, early phase trials, ensuring accordance with standard operating procedures (SOPs) and protocol-specific documents. The Manager works closely with clinic providers, faculty, research staff, compliance, and facilities.

 

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

Responsibilities

Management/ Leadership:

• Manage day-to-day operations of a team of lab technicians and operations specialists fostering teamwork-oriented environment.
• Contribute to the development, execution, and reporting of strategic goals for the clinical trial specimen processing lab.
• Communicate regularly with all lab personnel, both individually and as a group, to ensure consistent implementation of the laboratory practices.
• Support professional development for staff.
• Conduct employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the laboratory technical personnel.
• Develop and maintain strong collaborative relationships with internal and external research partners and sponsors and serve as a technical liaison.
• Meet and present to faculty and operations leadership across the Consortium.

Business Expertise and Operations: 

• Project laboratory staff, space, and equipment required to support growth and evolving needs of research portfolio
• Identify and lead process improvements, system implementation, and/or workflow changes to optimize quality and efficiency.
• In partnership with CRS leadership, develop and administer the annual laboratory budget and establish fee structures and policies to meet targets.
• In partnership with CRS and faculty leadership, set, track, and report  operational goals and Key Performance Indicators (KPIs)

Functional Research Knowledge: 

• Requires an in-depth understanding of processes and practices in clinical trial specimen handling/processing skills, and their application across a wide range of early phase, complex protocols. This includes, but is not limited to:
  • Specimen collection and processing to include separation of serum, plasma, and PBMC;
  • Microbiology technique execution – cell counting, cell separation, hematology blood smears; and
  • Sterile techniques utilizing biological safety cabinet.
• Understands clinic and research operations and identifies opportunities for collaborations and workflow and system integrations.
• Applies subject matter expertise to ide