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Guardant Health focused on rare-cell diagnostics
 
   Posted: Thursday, February 07, 2019
 
   
 
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JOB DETAILS
  Company Description

ABOUTOUR COMPANY

Guardant Health develops breakthrough diagnostic technologies to improve cancer management. With Guardant360, we offer real-time, biopsy-free tumor sequencing that tracks tumor genomics in real-time & identifies associated treatment options. The assay is used by more than 6,000 oncologists & we partner with more than 50 biopharma companies.

Guardant Health raised over $550M from Sequoia Capital, Khosla Ventures, Lightspeed Ventures, OrbiMed & Softbank, before having a successful IPO on NASDAQ in 2018. Guardant is led by a seasoned management team of thought leaders & successful serial entrepreneurs in next generation sequencing & rare cell diagnostics. They are advised by an oncologist-led medical steering committee from leading cancer centers.

Job Description

GENERAL SUMMARY:

TheClinical Trial Operations Internis 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:

  • Support management of the Trial Master File (TMF) to meet ICH/GCP requirements & work in conjunction with Clinical Trial Mangers & Clinical Trial Assistants to create & execute on study-specific TMF Plans
  • Prepare study related materials for the training of internal & external staff
  • Review regulatory packets for completeness & accuracy
  • Assist clinical teams with study supplies management
  • Prepare & distribute Investigator Site Files (ISFs)
  • Assist with tracking 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)
  • Track & collate clinical trial documentation related to Clinical Study Report (CSR) appendices
  • Support quality review of electronic Case Report Forms (eCRFs)
Qualifications

Knowledge, skills & abilities:

  • Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
  • Good interpersonal/communication skills
  • Detail oriented
  • Well organized, team-oriented individuals encouraged to apply
  • General knowledge of computers & navigating databases

Minimum certifications/educational level:

  • Bachelor's Degree candidate in biology-related field or equivalent healthcare or laboratory-related work experience
Additional Information

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

 
 
 
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