Clinical Research Associate I (Clinical Trials Operations)
Company: Guardant Health
Location: Redwood City
Posted on: June 20, 2022
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
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
- Minimum Bachelor's degree B.S in biological sciences or medical
- 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.
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
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:
Keywords: Guardant Health, Redwood City , Clinical Research Associate I (Clinical Trials Operations), Healthcare , Redwood City, California
Didn't find what you're looking for? Search again!