Clinical Research Associate I/II

4 weeks ago

Toronto, Ontario, Canada ICON Strategic Solutions Full time

As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

  • Oversee multiple oncology trials, ensuring high-quality execution
  • Provide leadership and mentorship to junior flex team members
  • Act as Lead SM, training and guiding other Site Managers on study protocols
  • Develop essential study start-up documents, including SIV agendas
  • Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
  • Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
  • Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
  • Support country budget development and contract negotiations in collaboration with CCS colleagues
  • Assist with ASV activities and ensure alignment with study objectives
  • Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

You Are:

  • Remote position located in Toronto
  • Bilingual - Proficient in both written and spoken French and English.
  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
  • At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
  • Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
  • Knowledge of risk-based/analytical monitoring approaches is an asset
  • Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Strong collaboration with investigators and site staff to meet study timelines
  • Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
  • Ability to work independently while being a strong collaborator
  • In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
  • Up to 50% regional travel required
  • To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status.

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