Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Clinical Research Associate l (CRA) is responsible for monitoring activities that will lead to successful execution of IVD clinical studies. They will proactively identify & resolve clinical project issues & participate in process improvement initiatives as applicable. The CRA engages with internal & external stakeholders as a member of the Clinical Trial Operations team.
- Assist in coordinating & conductingall aspects of study monitoring process (site initiation visits, interim monitoring visits, & close-out visits) to ensure site's compliance to the study protocol & applicable regulatory requirements.
- Prepare accurate & timely trip reports.
- Ensure compliance with GCP/ICH guidelines & 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 & instructions.
- Involved in the development of study documents including but not limited to training slides, protocols, & reports.
- Actively participates as a member of the study team & contributes to cross functional project team.
- Maintain accurate, professional, & timely sponsor/site correspondence & communication.
- Manage material logistics & acts as contact for clinical trial supplies & other suppliers (vendors) as assigned
- Assist trial team in ensuring that study management, data collection & subsequent data transfers are in accordance with outlined specifications (DTA/DTS).
- Acquires a basic understanding of the principles of the assay and/or instrument & "hands-on" knowledge.
- Prepares & presents project progress reports to keep management & team informed.
- Implements all policies, established procedures, & regulations into daily operations as appropriate. Develops professional, expertise via professional & educational opportunities.
- Demonstrates basic writing skills. (i.e. clear, concise, effective, & well-organized)
- Tries to understand changes in work tasks, situations, & 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 & effective work habits in a matrix environment, internally & externally.
- A flexible attitude to adjust to changing needs
- Excellent knowledge of MS Office as well as project management & clinical trials software.
- 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) & 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.
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 & will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
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