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Senior Clinical Study Coordinator

Company: Guardant Health, Inc.
Location: Redwood City
Posted on: June 8, 2021

Job 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 and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360, Guardant360 CDx and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

The Senior Clinical Study Coordinator is responsible for the daily administrative requirements performing high complexity laboratory testing (Next generation DNA sequencing) on patient specimens, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The work requires keeping meticulous and organized records, excellent attention to detail, the ability to multi-task, and be flexible with tasks and schedules. This individual works under the supervision of the Director of Clinical Operations with activities delegated by the Principal Investigator.

POSITION DUTIES

  • Facilitates the coordination and management of clinical studies
  • Assist principal investigator in day-to-day administrative requirements
  • Prepare records for trial monitoring activities and study binder maintenance
  • Perform procedures and analyses per the laboratory's standard operating procedures
  • Perform, review and document laboratory quality control procedures
  • Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications
  • Perform and document routine preventive maintenance
  • Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer
  • Perform other miscellaneous laboratory duties as assigned and assist others as time allows
  • Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field
  • 3+ years' experience in a CLIA, CAP accredited laboratory preferred
  • 3+ years' experience as a clinical research coordinator preferred, ideally in a lab or device setting
  • Project management experience preferred
  • SOCRA, ACRP or PMP certification preferred
  • GCP, GCLP experience required
  • Working knowledge of local, state, and federal laboratory regulations
  • Able to integrate and apply feedback in a professional manner
  • Organized, meticulous and thorough
  • Able to prioritize and drive to results with a high emphasis on quality
  • Ability to work as part of a team

Additional Information

  • Hours and days may vary depending on operational needs
  • Standing or sitting for long periods of time may be necessary
  • May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation (Generally Laboratory and Client Services employees only)
  • Repetitive manual pipetting may be necessary
  • Some lifting (up to 25 pounds) may be necessary

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 and will not be discriminated against on the basis of disability.

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

Please visit our career page at: http://www.guardanthealth.com/jobs/

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

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Keywords: Guardant Health, Inc., Redwood City , Senior Clinical Study Coordinator, Other , Redwood City, California

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