Company Description|Job Description
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.
The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup & management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects & general office work.
PRIMARY DUTIES & RESPONSIBILITIES:
- File, track & maintain the Trial Master File (TMF)
- Prepare study related materials for the training of internal & external staff
- Coordinate execution of Non-Disclosure & Confidentiality Agreements (NDAs) with study sites
- Review site-specific regulatory packets for completeness & accuracy
- Assist sites with study supplies management
- Prepare & distribute Investigator Site Files (ISFs)
- Track site payments & vendor invoices
- Conduct study closure activities (sites status, reconciliation activities, filing & archiving)
- Assist with meeting coordination, meeting materials & meeting minutes
- Track & collate clinical trial documentation related to Clinical Study Report (CSR) appendices
- Support quality review of electronic Case Report Forms (eCRFs)
Knowledge, skills & abilities:
- Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
- Good interpersonal/communication skills
- General knowledge of computers & navigating databases
- Well organized, team-oriented individuals encouraged to apply
Minimum certifications/educational level:
- Bachelor's Degree in biology-related field or equivalent healthcare or laboratory-related work experience
- At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred
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/