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Scientific. Clinical. Engineering

Clinical Trial Associate

New York City Metro Area, NY

Employment Type: Full-Time Job Type: Clinical Job Number: JN -082022-30758 Region: New York City Metro Area

Job Description

Required Skills & Experience:
  • Graduate of a secondary education or equivalent education, science degree preferred.
  • Minimum of 6 months to 1 year of clinical Trial Associate experience.
  • Demonstrate a working knowledge of ICH-GCP and regulatory guidance.
  • Solid working knowledge of eTMF platforms.
  • Detail oriented, strong interpersonal and organizational skills and ability to multitask.

Responsibilities:
  • Acts as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Ownership of eTMF (electronic Trial Master File) and management of eTMF.
    • Sets up, maintains, and reviews regulatory and administrative documents for the eTMF.
    • Obtains, reviews, and processes regulatory and administrative documents from investigator sites.
    • Tracks site compliance and performance of documentation within project timelines.
    • Assists with periodic review of study files including general and investigator site files to ensure all documentation is complete and up-to-date.

*Experienced candidates only please.

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