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 Assistant Clinical Study Coordinator is primarily responsible for the coordination of activities associated with the setup & management of clinical studies performed in the laboratory under the direction of, or as delegated by a member of the Clinical Study team. Responsibilities will range from clinical study coordination to data entry projects & general office work.
- Manage Investigator Site Files (ISF) & Site Study Binders (SSB) to meet ICH/GCP requirements & work in conjunction with Clinical Study Coordinators to create & execute on study-specific plans & protocols
- Assist principal investigator in day-to-day administrative requirements
- File, track, & maintain study activity
- Assist with preparing records for trial monitoring activities & study binder maintenance
- Assist team with study supplies management
- Conduct study tracking activities (sample status, reconciliation activities, filing & archiving)
- Assist with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, meeting materials (creating PowerPoint Presentations as directed by senior team members)
- Support quality review of study documentation
- Participate in process improvements for lab clinical studies
- Report all concerns of test quality and/or safety to the Laboratory Supervisor or Safety Officer
- Perform other miscellaneous laboratory duties as assigned & assist others as time allows
EDUCATION AND EXPERIENCE
- Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field
- 1 years' experience in a CLIA, CAP accredited laboratory preferred
- 1 years' experience as a clinical research coordinator preferred, ideally in a lab or device setting
- 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
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/