Company Description|Job Description
Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics.The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers
The Clinical Research Associate(CRA) for the LUNAR program is responsible for management & monitoring activities that will lead to successful execution of clinical studies. They will proactively identify & resolve clinical project issues & participate in process improvement initiatives as applicable. The CRA engages with study investigators, vendors & internal/external stakeholders as a member of the Clinical Trial Operations team.
Essential Duties & Responsibilities:
- Responsible for all aspects of study site monitoring including routine monitoring & close-out of clinical sites, maintenance of study files, conduct of pre-study & initiation visits.
- Involvement in the generation of project plans, especially those related to site management, monitoring & reporting.
- Involved in the development of protocols & Case Report Forms (CRFs) as assigned.
- Manage the identification, selection & feasibility processes.
- Ensure the study staff who will conduct the protocol have received the proper materials & instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures & protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review & monitor for missing or implausible data.
- Prepare accurate & timely trip reports.
- Organize & make presentations at Investigator Meetings.
- Interact with internal groups to evaluate needs, resources & timelines.
- Act as contact for clinical trial supplies & other suppliers (vendors) as assigned
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology
- Minimum of two(2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring & closeout visits) at a Pharmaceutical, Biotech or CRO company. Diagnostic and/or Medical device experience preferred.
- Oncology experience preferred
- Thorough knowledge of ICH/GCP Guidelines, including a basic understanding of regulatory requirements in other countries
- Advanced site monitoring skills
- The ability to thrive with minimal supervision
- The drive to resolve project-related problems & can prioritize workload for self & team
- Efficient & effective work habits in a matrix environment, internally & externally.
- A flexible attitude to adjust to changing needs
- The ability & willingness to travel up to 70% of the time.
- Excellent knowledge of MS Office as well as project management & clinical trials software.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & 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/