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Clinical Research Associate - Oncology

2+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Associate – Oncology (Montreal or Quebec City)


Location:

Montreal or Quebec City, Canada (Remote with Regional Travel)


Job ID:

2025-116997


Department:

Clinical Monitoring – ICON Strategic Solutions


Job Type:

Full-Time, Remote


Application Contact:

Name: Monica Hawkins
Options: View other roles or send a message via the application platform


Job Description:

As a Clinical Research Associate (CRA), you will oversee multiple oncology trials in Montreal or Quebec City, ensuring the high-quality execution of studies. The role also involves mentoring junior team members, managing site relationships, and supporting clinical trial processes, especially in oncology areas like Hematology, Prostate Cancer, Lung Cancer, and Early Phase Development (Phase 1).


Key Responsibilities:

  • Oversee and monitor multiple oncology trials ensuring quality execution

  • Lead and mentor junior Site Managers (SM), providing training and guidance

  • Develop essential study documents such as Site Initiation Visit (SIV) agendas

  • Represent Site Managers and Lead Trial Managers (LTMs) in key meetings

  • Ensure SM’s input is reflected in study documents like Monitoring Guidelines

  • Review site reports (SQV, SMV, SCV) for sites assigned to other SMs

  • Support country budget development and contract negotiations with CCS colleagues

  • Assist with ASV and ensure alignment with study objectives

  • Maintain compliance with KPIs and metrics outlined in the Quality Oversight Plan (QOP)


Interfaces:

  • Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team

  • Other: Investigators, Site Coordinators, Site Pharmacists, Local Drug Safety Officers, Regional Compliance Teams


Required Qualifications:

  • Location: Remote, must be based in Montreal or Quebec City

  • Bilingual in French and English (both written and spoken)

  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences

  • At least 2 years of experience in clinical trial monitoring in the pharmaceutical industry

  • Experience in oncology trials (preferred: Hematology, Prostate Cancer, Lung Cancer, Phase 1)

  • Knowledge of risk-based/analytical monitoring (preferred)

  • Proficiency in clinical trial systems (CTMS, EDC, TMF, IWRS, safety reporting tools)

  • Ability to drive patient recruitment strategies at assigned sites

  • Strong collaboration and communication skills with site staff and investigators

  • In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements

  • Up to 50% regional travel required

  • Must be legally authorized to work in Canada without future sponsorship


What ICON Offers:

  • Competitive salary with performance-based recognition

  • Health insurance packages for you and your family

  • Retirement and savings planning support

  • Global Employee Assistance Program (TELUS Health)

  • Paid annual leave and flexible work-life balance policies

  • Country-specific benefits: childcare vouchers, gym memberships, subsidized travel passes, etc.
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    Explore ICON Benefits


Diversity & Inclusion Commitment:

ICON values diversity, inclusion, and belonging, ensuring equal opportunity for all qualified candidates without discrimination.