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Sr. Clinical Study Coordinator

Company: Guardant Health
Location: Redwood City
Posted on: May 8, 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

Position Summary:

The Senior Clinical Study Coordinator is responsible for the management and monitoring activities which will lead to successful execution for laboratory 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. This individual will proactively identify and resolve laboratory study issues and participate in process improvement initiatives as applicable. Given the wide variety of tasks involved in this position, the Senior Clinical Study Coordinator must demonstrate the ability to collaborate with other departments, analyze complex issues, and make sound decisions in a timely manner.

Essential Duties and Responsibilities:

  • Act as the liaison between sponsor, Quality, and applicable site staff for laboratory studies
  • Facilitate the coordination and management of clinical studies
  • Manage study timelines in collaboration with other departments
  • 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
  • Familiar with the molecularly targeted therapies in oncology and general knowledge of genomic alterations in different cancers
  • Create and manage study files for GCP and non-GCP studies
  • Develop training materials for the clinical study coordination and the laboratory teams and conduct study related trainings
  • Host monitoring visits and close out action items in a timely manner
  • Create study overview procedures as applicable
  • File and review study related nonconformance reports
  • Participate in internal and external audit activities
  • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer

    Qualifications

    Qualifications:
    • Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field
    • Minimum 3 years' experience in Life Sciences/Medical Device Industry or Clinical Research
    • 2+ years' experience in a CLIA, CAP accredited laboratory preferred
    • Project management experience preferred
    • Oncology experience preferred
    • Thorough knowledge of ICH/GCP guidelines, including basic understanding of regulatory requirements in other countries
    • Ability to analyze and solve complex issues with minimal direction and make decisions or escalate concerns
    • Able to prioritize and drive to results with a high emphasis on quality
    • Able to integrate and apply feedback in a professional manner
    • Proven attention to detail and accuracy
    • High degree of initiative and self-motivation
    • Able to work effectively in a team environment and build strong working relationships
    • Effective interpersonal skills and ability to effectively communicate (verbal and written) across all levels of the company
    • Experience with MS Office suite and Internet for business use
    • Other: Clinical Laboratory certification (MT, ASCP or equivalent) or certification as a clinical research professional (SOCRA, ACRP) is desirable

      Work Environment:
      • 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.

        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 , Sr. Clinical Study Coordinator, Healthcare , Redwood City, California

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