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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 Clinical Research Associate (CRA) II supports the processing & analysis of research samples, both from biopharma clients & clinical research projects. Whether it is helping understand how patients are responding to investigational therapies or accelerating our understanding of resistance & tumor evolution, the CRA II has a critical role in driving forward customers' understanding of tumor genomics through circulating tumor DNA sequencing.

Essential Duties & Responsibilities:

  • Report & cancel pharmaceutical & institutional samples;
  • Enter, verify, upload data, document, monitor & change sample status in the Laboratory Information System database;
  • Log & track Clinical Research samples, then notifying Client Services, Alliance Management, Clinical Development & Clinical Trials Teams;
  • Support RUO & IUO reporting activity;
  • Monitor & ensure prompt turnaround time of samples;
  • Prepare & organize preliminary reports for review;
  • Support the administrative functions of the lab as required;
  • Perform, review & document quality control procedures;
  • Filing documents, such as reports & test requisition forms;
  • Document all corrective actions taken when test systems deviate from reporting established performance specifications;
  • Review, record, interpret, report, & amend results as assigned;
  • Lead training of new reporting personnel & training of new & existing procedures with existing personnel;
  • Analyze data & troubleshoot issues with the LIS & Business Development teams;
  • Participate in the inspection preparation activities as needed;
  • Communicate effectively with coworkers & non-laboratory personnel;
  • Write & review of procedures, documents & forms; and
  • Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer;
  • Leading & delegating study binder activities;
  • Participate & provide input for new product launches by attending meetings
  • Minimum of two yearsof working in a biotechnology environment;
  • Previous laboratory experience preferred;
  • Associate or Bachelor degree in Biomedical Laboratory Science, Clinical Science or related field or equivalent work experience;
  • Attention to detail;
  • 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;
  • Experience in molecular biology techniques preferred;
  • Ability to proactively communicate consistently, clearly, & honestly;
  • Strong communicator with ability to maintain open communication with internal employees, managers & customers as needed;
  • Strong automation & computing skills;
  • Strong technical skills & job & industry knowledge;
  • Strong professionalism & leadership skills;
  • 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;
  • 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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