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 Associatell (CRA) is responsible for management & monitoring activities that will lead to successful execution of IVDclinical 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.
- Responsible for all aspects of study site monitoring including pre-study, initiation, interim, & close-out monitoring visits of clinical sites.
- Involved in the development of study protocols, reports, & data transfer specifications (DTS.
- Manage or coordinate all aspects of the clinical monitoring process in 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.
- Manage the identification, selection & feasibility processes.
- Ensure the study staff who will conduct the protocol have received the proper materials & instructions.
- Prepare accurate & timely trip reports.
- Maintain & document professional communication with the study sponsor, clinical sites, cross functional project team & management throughout the duration of the study.
- Participates in the development & maintaining of standard operating procedures.
- Manages material logistics & acts as contact for clinical trial supplies & other suppliers (vendors) as assigned
- Ensures accurate & complete study management/data collection & transfer to data management
- Assists, prepares & manages study timelines.
- Acquires a basic understanding of the principles of the assay and/or instrument & "hands-on" knowledge.
- Actively participates as a member of the cross-functional project team.
- Maintains accurate & timely sponsor/site correspondence & communication.
- 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 3 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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