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Guardant Health focused on rare-cell diagnostics
 
   Posted: Tuesday, November 20, 2018
 
   
 
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JOB DETAILS
  Company Description

ABOUT OUR COMPANY

Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.

In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.

Job Description

TheClinical 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 study activity within the Clinical Trial Management System (CTMS)
  • Managethe electronic Trial Master File (eTMF) to meet ICH/GCP requirements & work in conjunction with Clinical Trial Mangers to create & execute on study-specific TMF Plans
  • Prepare study related materials for the training of internal & external staff
  • Coordinate execution of Non-Disclosure & Confidentiality Agreements (NDAs) with study sites
  • Review regulatory packets for completeness & accuracy
  • Assist clinical teams with study supplies management
  • Prepare & distribute Investigator Site Files (ISFs)
  • Track departmental payments & vendor invoices
  • Conduct study tracking activities (sites 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), & coordination of travel arrangements, dinner reservations, car service, off-site meeting rooms)
  • Track & collate clinical trial documentation related to Clinical Study Report (CSR) appendices
  • Support quality review of electronic Case Report Forms (eCRFs)
Qualifications
  • Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
  • Previous experience with Veeva CTMS/eTMF is highly preferred
  • Good interpersonal/communication skills
  • General knowledge of computers & navigating databases
  • Well organized, team-oriented individuals encouraged to apply
  • 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
Additional Information

All your information will be kept confidential according to EEO guidelines.

This description is used as a guideline for major duties. The company reserves the right to change or assign additional duties as needed.

 
 
 
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