CRS Clinical Trial Specimen Processing Specialist II

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 II - 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 II will support the management of 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 participate in 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 Support:

Demonstrate mastery of most clinical research specimen handling/processing skills, and their application across a wide range of early phase, complex protocols including but 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.

Research Development:

• Establish and maintain positive, collaborative working relationships with faculty, research staff, and clinic operations to help ensure services and user interfaces align with research needs.
• Identify opportunities for improvement of laboratory workflow while adhering to study specified protocols and procedures.
• Work with senior staff to implement process changes and system enhancements to optimize laboratory workflow and capacity.
• Develop appropriate protocols or creative solutions and deliver high quality data.

Equipment, Supplies, and Systems Management:

• Perform advanced equipment operation and maintenance or coordinate and complete maintenance on service-related equipment and software.
• Review and identify new equipment and system needs.
• Assist with lab supply and space management.
• Preparation of research lab kits for patient blood draws.
• Monitor and maintain research laboratory kit supply.

Training and Oversight:

• Assist in the development of SOPs, training materials, and guidelines.
• Present new or expanded specimen processing lab technologies.
• Conduct literature reviews to assist in determining most suitable methods for technical development and improvement.
• Periodically check accuracy of lab processes and communicate any issues with the lab leadership

Administrative Tasks:

• Contribute to lab service billing and some cost accounting.

Regulatory and Compliance

• Maintain placeholders and upload documentation to electronic regulatory binder.
• Track shipment and obtain proof of delivery along with electronic documentation to electronic regulatory binder.
• Work according to applicable federal, state, and local clinical research regulations and maintain rigorous Good Documentation Practices standard for all laboratory work.

MINIMUM QUALIFICATIONS:

• Master's degree in biology, microbiology, biochemistry, or a related field;OR
• Bachelor's degree in biology, microbiology, biochemistry, or related and 2 years of laboratory experience; OR
• Associate degree and 5 years of laboratory experience; OR
• GED/High School Diploma and 7 years of laboratory experience.

PREFERRED QUALIFICATIONS:

• Demonstrated ability to learn and adapt to new systems and techniques.
• Ability to operate processing equipment in accordance with biosafety standards.
• Strong understanding of GCP as relates to processing of clinical specimens.
• Excellent communication skills and organizational skills.
• Ability to work in a collaborative team-oriented, core-lab environment.
• Experience with MS Office suite of applications (Outlook, Word, Excel, SharePoint, Teams, One Drive, etc.).
• Excellent record keeping and data management.

The hourly pay range for this position is from $31.83 to $47.73 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).