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Clinical Research Associate I / II - Oncology - Toronto
ICON Strategic SolutionsOntario, Canada, Canada
14 days ago
Job type
Full-time
Job description
As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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.