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Clinical Trial Assistant

The Clinical Trial Assistant will assist the study team with the planning and implementation of clinical research projects.

Responsibilities:

  • Assist with formatting/production and distribution of key study documents such as investigator brochures, protocols, interim safety reports, and site educational an reference material
  • Assist with investigator recruitment by making initial site contact, obtaining confidentiality agreements, forwarding study synopsis to sites and administering feasibility questionnaires
  • Facilitate submission of regulatory documents to a central institutional review board (IRB) and coordinate collection, tracking, and maintenance of updated site regulatory documentation
  • Participate in organizing investigator meetings including venue selection, invitations, agenda and materials distribution
  • Track clinical supply inventory at sites and manage the site drug re-supply process
  • Set-up and maintain tracking system with oversight of manager
  • Develop working knowledge of company standard operating procedures (SOPs) and FDA regulations related to clinical studies

Requirements:

  • BA/BS or equivalent work experience
  • 3+ years’ experience in pharma related industry

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Knowledge of GCP regulatory requirements
  • Ability to read and understand scientific literature
  • Excellent verbal and written communication skills
  • Strong proficiency in Microsoft Office

If you are interested, please submit your resume by email to hr@corcept.com

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