Clinical Research Associate I (Clinical Development)
Guardant HealthFull time Full day
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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and 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 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.
- 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 opportunities.
- 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.
- 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) 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.
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.
Please visit our career page at: http://www.guardanthealth.com/jobs/