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Clinical Trial Assistant

SUMMARY DESCRIPTION

The Clinical Trial Assistant position is a key support role within Clinical Operations, undertaking essential coordination activities for the study team.

The CTA will primarily have the Clinical Trial Assistant role on studies and focus on the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by, the Study Lead or study CRA.

Following demonstrated success in the role, the CTA may have the opportunity to perform site support for one clinical research site.

 

RESPONSIBILITIES

Study Coordination

Assist with study coordination activities, including:

  • Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
  • File, track and maintain TMF
  • Maintain internal/external contact list
  • Conduct electronic documentation and records management
  • Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
  • Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
  • Ensure timely study entry and updates to ClinicalTrials.gov
    • Prepare investigator meeting materials
    • Design and prepare study related materials for the training of internal and external staff  Study ConductAssist with study conduct activities, including:Startup
  • Facilitate CDA and contract execution. Assist with regulatory package review.
  • Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study CRA or Study Lead.
  • Contact and identification of investigators for participation in clinical studiesEnrollment and Maintenance
  •  Issues identification, resolution, and escalation
  • Track site payments and vendor invoices
  • Closure:
  • Conduct study closure activities (sites, reconciliation activities, filing & archiving)
  • Track, collate clinical trial documentation related to CSR appendicesCross-functional Representation           
  • May assist with cross-functional meeting coordination and minutesAdditional      
  • May assist with study supplies management
  • May assist with TMF maintenance

SCOPE

 

The CTA is expected to demonstrate foundational communication skills, including an ability to ensure that important information is consistently shared with managers, peers, team members, and business partners in a timely manner and an ability to facilitate functional team meetings. The CTA should also demonstrate proactivity and initiative, including reliably delivering on assignments and demonstrating a willingness to receive feedback and course correct.

BA/BS or in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered. 

 

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