Clinical Research Associate- Toronto - ICON

ICON
ICON
Verified Company
Toronto, Canada

2 weeks ago

Sophia Lee

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Sophia Lee

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Description
ICON is looking for a Clinical Research Associate in Toronto Oncology experience is preferred


What you will be doing:


  • Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
  • Oversee and report on the conduct of clinical trials at a site level including and online site visit reports and updates to electronic management systems
  • Proactive site management including:
  • Building and maintaining solid and professional relationships with site staff
  • Maintaining site audit/inspection readiness
  • Ensuring appropriate safety reporting and use of online safety reporting/reviewing systems such as Intralinks
  • Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
  • Responding to site queries and escalating issues in accordance with processes and timelines
  • Conducting IP accountability and reconciliation
  • Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
  • Maintenance of site study supplies

Operational Excellence:

  • Contribute to sponsor goals
  • Promote operational and scientific excellence
  • Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.

You are:


  • BA/BS/BSc in the sciences or nursing equivalent
  • A trained CRA with onsite monitoring experience
  • Comprehensive knowledge and understanding of ICH-GCP
  • Fluent oral (face to face and telephone) and written English language skills
  • Able and willing to travel up to 60% of the time or as per local requirements
  • Possession of a full driver's license
  • Able and willing to work from a designated and appropriate home office as per local requirements
  • Willing to attend and contribute to team meetings including mandatory training (remote/offsite)
  • Competent computer skills including working knowledge of common software packages
  • Working knowledge of trial management databases and online systems
  • Able to attend a 1 week face to face inhouse training course as part of onboarding training
  • Able and willing to work on several protocols/therapy areas
  • Experience in phase II and phase III trials (preferred)
  • Working knowledge of Electronic Data Capture (preferred)
Experience/working knowledge of the oncology disease area (preferred)

  • Experience of Centralized/Risk Based/Targeted monitoring (preferred)
  • Experience of working within a metric based environment (preferred)

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