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Clinical Research Associate I (Clinical Trials Operations)

Company: Guardant Health
Location: Redwood City
Posted on: June 20, 2022

Job Description:

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360 -, Guardant360 CDx, Guardant360 TissueNext---, Guardant360 Response---, and GuardantOMNI - tests for advanced stage cancer patients, and Guardant Reveal--- for early-stage cancer patients. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

Job Description

The Clinical Research Associate (CRA) is responsible for monitoring activities that will lead to successful execution of IVD clinical studies. They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. The CRA engages with internal and external stakeholders as a member of the Clinical Trial Operations team.

Essential Duties and Responsibilities:

  • Assist in coordinating and conducting all aspects of study monitoring process (site initiation visits, interim monitoring visits, and close-out visits) to ensure site's compliance to the study protocol and applicable regulatory requirements.
  • Prepare accurate and timely trip reports.
  • Ensure compliance with GCP/ICH guidelines and regulations including review of all required essential documents necessary for study initiation to ensure audit ready study files throughout the duration of the study.
  • Confirm that study staff who will conduct the protocol have received the proper materials and instructions.
  • Involved in the development of study documents including but not limited to training slides, protocols, and reports.
  • Actively participates as a member of the study team and contributes to cross functional project team.
  • Maintain accurate, professional, and timely sponsor/site correspondence and communication.
  • Manage material logistics and acts as contact for clinical trial supplies and other suppliers (vendors) as assigned.
  • Assist trial team in ensuring that study management, data collection and subsequent data transfers are in accordance with outlined specifications (DTA/DTS).
  • Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge.
  • Prepares and presents project progress reports to keep management and team informed.
  • Implements all policies, established procedures, and regulations into daily operations as appropriate. Develops professional, expertise via professional and educational opportunities.

    Qualifications
    • Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred.
    • Minimum of 1-2 years' experience in clinical research, in-vitro diagnostics, CLIA laboratory.
    • Preferred knowledge of regulations (CFR / GCP) and standards (ICH) affecting IVDs.
    • Preferred site monitoring of in vitro diagnostic device trials or clinical laboratory assay/instrument experience.
    • Preferred oncology experience.
    • Other: Clinical Laboratory certification (MT,ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.
    • Demonstrates basic writing skills. (i.e. clear, concise, effective, and well-organized).
    • Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change.
    • The ability to thrive with minimal supervision.
    • The ability to drive aa resolution for project-related problems while prioritizing workload.
    • Efficient and effective work habits in a matrix environment, internally and externally.
    • A flexible attitude to adjust to changing needs.
    • Excellent knowledge of MS Office as well as project management and clinical trials software.

      Additional Information

      Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.

      Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and 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 and will not be discriminated against on the basis of disability.

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

      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.

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

Keywords: Guardant Health, Redwood City , Clinical Research Associate I (Clinical Trials Operations), Healthcare , Redwood City, California

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