Clinical Trial Assistant

San Rafael, CA 94901

Posted: 09/12/2019 Employment Type: Contract Industry: Clinical Job Number: 6856

Job Description


Clinical Trial Assistant

Contract- 1 year

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

The Clinical Trial Assistant is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Analysis, Problem solving and Decision Making.

For example:
  • Responds promptly with clear, organized written and oral communication
  • Takes ownership and accountability for completing assigned tasks and perseveres through obstacles
  • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly

Job Requirements

Study Start Up:

  • Provide administrative assistance with internal and external meetings including investigator meeting(s)
  • Request and distribute insurance policy/certificates (see Insurance section)
  • Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)
  • Ensure accurate study entry and updates to ClinicalTrials.gov

Study Conduct and Close-out:

  • Ensure MVR tracking and filing of sponsor comments
  • Identify issues, with potential resolution, and escalate when appropriate
  • Assist in the conduct of study close-out activities (sites, reconciliation activities, filing & archiving)
  • Track and collate clinical trial documentation related to CSR appendices
  • The Clinical Trial Assistant is also assisting in insurance and investigational product related activities

Education:          

  • BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
  • 1-year pharmaceutical industry experience
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