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Clinical Study Coordinator

Company: Guardant Health
Location: Redwood City
Posted on: June 13, 2022

Job Description:

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 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.

Job Description

The Clinical Study Coordinator is responsible for the management and monitoring activities which will lead to successful execution of clinical studies. The work requires keeping meticulous and organized records, excellent attention to detail, the ability to multitask, and to be flexible with tasks and schedules. They will proactively identify and resolve clinical study issues and participate in process improvement initiatives as applicable.

Essential Duties and Responsibilities:

  • Acts as the liaison between Clinical Development, Quality, and applicable site staff for clinical studies
  • Ensure compliance with ICH/GCP guidelines and regulations including review of all essential documents necessary for study initiation to ensure audit ready study files throughout the duration of the study
  • Prepare all documentation for monitoring visits (initial, continuing, and close-out)
  • Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge
  • Maintain accurate, professional and timely site/sponsor correspondence and communication
  • Involvement in process improvement initiatives regarding clinical studies and the lab
  • Involved in the development of supplemental study material when applicable
  • Implements all policies, established procedures, and regulations into daily operations as appropriate. Develops professional expertise through professional and educational opportunities
  • Create and manage study binders for GCP and non-GCP studies
  • Develop training materials for the clinical study coordination and laboratory teams and conduct study related training
  • Host monitoring visits and close out action items
  • Create study overview procedures as appropriate
  • Perform other miscellaneous duties as assigned and assist others as time allows

    Qualifications
    • Bachelor of Arts or Science in biological sciences preferred
    • 1-2 years experience in Life Sciences Industry or Clinical Research
    • 1+ years' experience in a CLIA, CAP accredited laboratory preferred
    • Preferred oncology experience
    • Preferred knowledge of ICH/GCP guidelines, including a basic understanding of regulatory requirements in other countries
    • Ability to analyze and solve issues with minimal direction and make decisions and/or escalate complex issues, concerns
    • Able to prioritize and drive to results with a high emphasis on quality
    • Able to integrate and apply feedback in a professional manner
    • Able to work effectively in a team environment and build strong working relationships
    • Proven attention to detail and accuracy
    • High degree of initiative and self-motivation
    • Effective interpersonal skills and the ability to effectively communicate (verbal and written)
    • Perform other miscellaneous duties as assigned and assist others as time allows
    • Other: Certification as a clinical research professional (SOCRA, ACRP) is desirable
    • Experience with MS Office suite and Internet for business use

      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/

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Keywords: Guardant Health, Redwood City , Clinical Study Coordinator, Healthcare , Redwood City, California

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