Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

GENERAL SUMMARY:

The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup and 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 and general office work.

PRIMARY DUTIES & RESPONSIBILITIES:

• File, track and maintain the Trial Master File (TMF)
• Prepare study related materials for the training of internal and external staff
• Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs) with study sites
• Review site-specific regulatory packets for completeness and accuracy
• Assist sites with study supplies management
• Prepare and distribute Investigator Site Files (ISFs)
• Track site payments and vendor invoices
• Conduct study closure activities (sites status, reconciliation activities, filing & archiving)
• Assist with meeting coordination, meeting materials and meeting minutes
• Track and 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 and navigating databases
• Well organized, team-oriented individuals encouraged to apply
• Proficient in Microsoft Office suite (Word, Excel, PPT)

Minimum certifications/educational level:

• Bachelor’s Degree in biology-related field or equivalent healthcare or laboratory-related work experience

Minimum 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 and use office equipment.  Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and 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 and 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/

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