Clinical Trials Assistant (Clinical Trial Operations)

10 Nov 2024

Vacancy expired!

Job Description

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)

Qualifications

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

Covid Vaccination Policy:Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation.Anemployee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this Policy by obtaining, if applicable, any FDA-approved boosters.

Additional Information

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.

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  • ID: #22528991
  • State: California Redwoodcity 94061 Redwoodcity USA
  • City: Redwoodcity
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2021-11-10
  • Deadline: 2022-01-07
  • Category: Et cetera