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.
- Manage relationship with pharmaceutical partner for operational execution of studies including start-up, maintenance, & close-out.
- Work cross-functionally with other Guardant Health departments (such as Bioinformatics, Clinical Operations, Regulatory Affairs, Client Services, etc.) to ensure timely execution ofstudyprotocols in accordance with Good Clinical Practices (GCPs).
- Identify barriers to timely & successfulstudyexecution & propose creative solutions in order to deliver project milestones.
- Assess feasibility ofstudytimelines & pharmaceutical partner requirements.
- Coordinate with pharmaceutical partner to establish reporting requirements & align with internal stakeholders to deliver reports. Finalize Data Transfer Agreements (DTA) & Data Transfer Specifications (DTS) as needed.
- Overseestudymonitoring to ensure compliance to thestudymonitoring plan by planning monitoring visit schedule, reviewing & approving monitoring reports, & providing guidance to monitors.
- Responsible forstudytraining of investigative site staff & providing ongoing educational assistance to ensure compliance withstudyprotocol & applicable regulatory requirements.
- Manage Clinical Research Associates & Clinical Trial Assistants to foster departmental growth, consistency, & compliance.
- Develop & approvestudymaterials including SIV slides, Lab Manuals, Communication Plans, etc.
- Ensure Clinical Development activities remain within the scope of the respective SOW/contracts & trackstudypayment milestones.
- 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 a 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.
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/