CRS Clinical Trials Specimen Processing 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. 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.

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 identify and resolve technical and operational problems and provide solutions based on judgement and analysis of current literature and other information.

Research Development:

• Develop new services and methodologies independently or with minimal input and based on user needs and trial pipeline.
• Oversee and approve validation of new assays.
• Support Specialist roles in collaborative projects with stakeholders.

Equipment, Supplies, and Systems Oversight:

• Serve as technical advisor to direct reports serving as a resource for optimization of lab performance and efficiency
• Identify, review and develop Capital Equipment request justification for new equipment in support of goals and projected trial portfolio growth.
• Provide major input in laboratory design in the clinic and oversee laboratory safety.
• Develop research lab workflows within Open Specimen and EPIC in collaboration with IT leadership; identify and serve as operational lead for new or expanded system implementations and integrations.
• Oversee use and management of lab chemicals, supplies, and research kits.

Training, Education, and Quality Management:

• Teach, develop, and expand scientific and technical expertise and training materials for the staff, and user base.
• Hire and train staff; ensure that laboratory personnel are adequately trained, equipped, and motivated to follow laboratory best practices.
• Ensure that all laboratory personnel are trained to the current version of the standard operating procedures.
• Maintain and improve lab's QA/QC program based on laboratory best practices.
• Maintain adequate records of all daily, weekly, and monthly QA/QC variables and the relative corrective actions.
• Maintain and update the laboratory standard operating and safety procedures.
• Analyze data, prepare reports, and make recommendations for improving laboratory operations.

People/ Interpersonal Skills:

• Coach team on daily deadlines and work with team to adapt plans and priorities to meet and resource or operational challenges
• Resolve challenges, monitor resources and output.
• Work to gain cooperation of others, either internally or externally
• Other duties as assigned.

MINIMUM QUALIFICATIONS:

• A minimum of 1 year of relevant management experience AND
• PhD and 3 year of relevant scientific experience OR
• Master's degree and 6 years of relevant scientific experience OR
• Bachelor's degree and 8 years of relevant scientific experience OR
• Associate Degree and 16 years of relevant scientific experience OR
• GED/ High School Diploma 18 years of relevant scientific experience
• Field of Education: medical research or related field

PREFERRED QUALIFICATIONS:

• Demonstrated ability to learn and adapt to new systems and techniques
• Extensive knowledge and laboratory experience in multiple aspects of drug discovery research including in vitro assays, pharmacokinetics, toxicology
• Experience working in a core lab environment
• Excellent communication and organizational skills
• Ability to work in a collaborative team-oriented environment
• Capable of undertaking work with minimal supervision and ability to manage multiple projects simultaneously
• Experience in working with internal and external research partners and maintaining strong relationships
• Familiarity with Phase 1 Clinical Trials laboratory practices, including writing of technical documentation and SOPs
• Proficient in the concurrent management of multiple projects of varying complexity and in rapidly implementing new projects/workflows
• Exceptional data management ability and strong organization skills
• Experience in generating and evaluating "scope of work" documentation and calculating budgets for projects
• Established technical expertise to serve as a resource for research unit/department.
• Knowledge of EPIC, OpenSpecimen, Florence, OnCore CTMS, and oncology clinical processes

The annual base salary range for this position is from $115,169 to $182,020, and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

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), and paid parental leave (up to 4 weeks).