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.
ABOUT THE ROLE
The Clinical Study Coordinator is responsible for the management & monitoring activities which will lead to successful execution of performing high complexity laboratory testing (Next generation DNA sequencing) on patient specimens, performing quality control & quality assurance procedures, & complying with all applicable local, state & federal laboratory requirements. The work requires keeping meticulous & organized records, excellent attention to detail, the ability to multi-task, & to be flexible with tasks & schedules. This individual works under the supervision of the Director of Clinical Operations with activities delegated by the Principal Investigator.
- Facilitates the coordination & management of clinical studies
- Independently identify & troubleshoot high complexity problems which adversely affect clinical studies
- Interact with internal groups to evaluate needs, resources, & timelines
- Assist with training of new study coordinators
- Assist with developing Standard Operating Procedures or supplemental study material
- Perform annual review of Standard Operating Procedures
- Prepare records for trial monitoring activities & study binder maintenance
- Review protocols & procedures for clinical studies & compare with the laboratory's standard operating procedures
- Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications for clinical studies
- Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer
- Participate in process improvements for lab clinical studies
- Perform other miscellaneous duties as assigned & assist others as time allows
- Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field
- 2 years' experience in a CLIA, CAP accredited laboratory preferred
- 3 years' experience as a clinical research coordinator preferred, ideally in a lab or device setting
- Project management experience preferred
- SOCRA, ACRP or PMP certification preferred
- GCP, GCLP experience required
- Working knowledge of local, state, & federal laboratory regulations
- Able to integrate & apply feedback in a professional manner
- Organized, meticulous & thorough
- Able to prioritize & drive to results with a high emphasis on quality
- Ability to work as part of a team
PHYSICAL DEMANDS/WORKING ENVIRONMENT
- Hours & days may vary depending on operational needs
- Standing or sitting for long periods of time may be necessary
- May be exposed to hazardous materials, blood specimens & instruments with moving parts, heating or freezing elements, & high speed centrifugation (Generally Laboratory & Client Services employees only)
- Some lifting (up to 25 pounds) may be necessary
- We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information & to apply.
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/