CRS Clinical Trial Specimen Processing Specialist IV

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 Research Support (CRS) Specialist IV- Clinical Trial Specimen Processing is responsible for supporting oncology clinical trials conducted within the Fred Hutch, University of Washington, Seattle Children's Cancer Consortium (Consortium). The CRS Specialist IV will manage 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 is responsible for handling and processing high volumes of clinical trial specimens for complex, early phase trials, in accordance with standard operating procedures (SOPs) and protocol-specific documents. This position will lead the creation and management of SOPs, training, system implementation/adoption, and related process improvements. This position collaborates with clinic providers, faculty, and research staff.

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.

Research Functional Knowledge:

Demonstrate mastery of 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.
• Record and organize human specimens for shipment to central laboratories
• Work under the direction of the CRS leadership and higher-level laboratory personnel.
• Use discretion and judgment in performance of duties.
• Independently interpret/apply study lab manuals.
• Support lab manual abstraction/review for study initiation, create protocols in lab software (OpenSpecimen) to track all research kit collection, processing, and shipment.
• Independently coordinate and conduct lab operations as needed.
• Independently complete laboratory requisition forms and PK processing documents.
• Problem-solve with minimal input from manager.

Research Development:

• Review protocol and laboratory manual for accuracy and modify laboratory collection guides for protocol amendments.
• Develop advanced protocols to support researcher's goals and deliver high quality results.
• Propose and initiate process changes and system enhancements with some input from leadership.

Equipment, Supplies, and Systems Management:

• Independently perform advanced equipment operation and maintenance or coordinate and complete maintenance on service-related equipment and software.
• Be, or through training, become an expert on equipment and systems required for operations.
• Serve as a resource for optimization of lab performance and efficiency.
• Perform advanced diagnostics and communicate with vendor for service / maintenance
• Participate in the review and identification of new equipment needs.
• Assist with lab supply and space management.
• Preparation of research lab kits for patient blood draws.
• Monitor and maintain research laboratory kit supply.
• Create protocols in OpenSpecimen software to track all research kit collection, processing, shipment
• Maintain placeholders and upload documentation to Florence ebinder

Training and Quality Oversight:

• Lead initiatives to develop new training materials, SOPs, guidelines, and methods to optimize lab workflows and user experience.
• Present on applicable new or expanded technologies including systems and equipment.
• Train and mentor current and incoming staff.
• Audit electronic documentation for accuracy to be compliant with all central research documentation requirements
• Review protocol and laboratory manual for accuracy and modify laboratory collection guides

Administrative tasks:

• Assist with management of lab service billing and cost accounting; identify cost-saving opportunities.
• Accurate documentation of laboratory activities.
• Create project prioritization, scheduling, and/or batching.

People/ Interpersonal Skills:

• Provide a high level of support for faculty and research staff users by establishing and maintaining a positive and collaborative working relationships with users and stakeholders.
• Communicate with researchers and foster positive relationships with vendors and facilities who support lab operations.
• Model the following items such as successful research practices, Fred Hutch's commitment to workplace respect, diversity, equity, inclusion, and research integrity and uphold a culture of support.

MINIMUM QUALIFICATIONS:

• PhD and 1 year of relevant scientific experience OR
• Master's degree and 4 years of relevant scientific experience OR
• Bachelor's degree and 7 years of relevant scientific experience OR
• Associate Degree and 11 years of relevant scientific experience OR
• GED/ High School Diploma 13 years of relevant scientific experience
• Field of Education: medical science or related field

PREFERRED QUALIFICATIONS:

• Demonstrated ability to learn and adapt to new systems and techniques.
• Expertise in clinical trial specimen handling/processing] procedural techniques
• Ability to work in a collaborative team-oriented, lab environment
• Experience with MS Office suite of applications (Outlook, Word, Excel, SharePoint, Teams, Power Apps)
• Record keeping and database management
• Capable of undertaking work with minimal supervision and ability to manage multiple projects simultaneously
• Can perform detailed research and review of technology through literature searches, outreach to experts in field and other informational sources
• Experience in Good Clinical Laboratory Practices (GCLP)
• Demonstrated experience in project management or equivalent relevant experience
• Effective organizational and problem-solving skills
• Ability to work on multiple projects and work independently with minimal supervision
• Strong interpersonal, teamwork and customer service skills

The annual base salary range for this position is from $88,712 to $133,057, 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).