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  Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.

Job Description

The Lead Clinical Research Accessioner (CRA) provides a vital link between Alliance Management, Clinical Development, Clinical Trials, Medical Affairs & the Clinical Operations teams. The Lead CRA is responsible for receiving, unpacking, processing & recording samples sent for laboratory testing.In addition, the Lead CRA serves as a team lead to the designated Accessioners in the Clinical Research team.Lastly, the Lead CRA is to communicate & coordinate tasks, divide workloads & manage projects.

The Lead Clinical Research Associate supports the team with the growing sample volume & increased complexity: juggling samples from various sources, processing across many panel types to meet turnaround times. The Lead Clinical Research Accessioner works with the Research Associates within the team & manages the Clinical Research Accessioning team & acts as an interface with multiple teams including Biopharma Business Development, Technology Development, Process Engineering, Clinical Operations, Bioinformatics, & the Laboratory Information Management System Team.

  • Perform sample intake & accessioning
  • Receive, unpack & process incoming clinical biohazardous specimens
  • Enter & verify data into Laboratory Information Management Systems (LIMS)
  • Prepare samples for testing by centrifuging & isolating plasma from whole blood
  • Resolve & document incomplete or unacceptable specimens
  • Create sample batches, print labels & label tubes & batches
  • Support the administrative functions of the lab as required
  • Check, monitor & record temperature & perform root cause analysis of deviations & implement a resolution or initiate a service request when necessary
  • Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
  • Perform, review & document laboratory quality control procedures;
  • Perform equipment maintenance & maintain equipment logs & records according to the laboratory's standard operating procedures;
  • Log & track research samples
  • Maintain appropriate inventory of lab supplies
  • Support the cleanliness of the laboratory by organizing & disinfecting racks, benchtops, freezers, fridges, & other laboratory equipment;
  • Keep laboratory equipment in good working condition by applying quality control measures, by performing & documenting routine preventive maintenance
  • Operate, maintain & troubleshoot equipment according to the laboratory's standard operating procedures;
  • Leads training of new laboratory personnel & training of new procedures with existing personnel
  • Participate in the inspection preparation activities as needed
  • Actively introduces process improvements, new assay configurations & validation
  • Maintain & track receipt & sample work in progress numbers
  • Communicate effectively with coworkers & non-laboratory personnel;
  • Write & review of procedures, documents & forms; & assisting with study binders;
  • Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer.
  • Filing documents, such as reports & test requisition forms.
  • Three years' experience of hands-on laboratory experience preferred;
  • Previous laboratory experience preferred;
  • Associate or Bachelor degree in Biomedical Laboratory Science, Clinical Science or related field or equivalent work experience;
  • Attention to detail, safety, & good laboratory practices;
  • Able to integrate & apply feedback in a professional manner;
  • Able to prioritize & drive to results with a high emphasis on quality;
  • Ability to work as part of a team;
  • Ability to proactively communicate consistently, clearly, & honestly;
  • Strong automation & computing skills preferred;
  • Strong technical skills & job & industry knowledge;
  • Strong professionalism & leadership skills; and
  • Strong project management abilities.

Work Environment:

  • Hours & days may vary depending on operational needs.
  • Standing or sitting for long periods of time may be necessary.
  • Exposure to hazardous materials, blood specimens & instruments with moving parts, heating or freezing elements, & high-speed centrifugation.
  • Repetitive manual pipetting may be necessary.
  • Some lifting (up to 25 pounds) may be necessary.
Additional Information

Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status & will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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