Senior Clinical Research Associate
About The Position
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. What You’ll Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs Ce Que Vous Ferez: Servir de point de contact principal entre les sites d’études et le promoteur Effectuer tous les types de visites sur site, y compris la sélection, l’initiation, la surveillance de routine et la clôture Assurer la conformité du site aux normes ICH-GCP, aux SOPs et aux règlements de Santé Canada Maintien la documentation à jour dans les systèmes CTMS et eTMF Soutenir et suivre la formation du personnel du site et tenir les dossiers de conformité à jour Surveiller la sécurité des patients, en assurant un signalement rapide et précis des AE/SAE/PQC Appuyer les efforts de recrutement et de rétention des participants à l’étude au niveau du site Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou leur destruction appropriée Résoudre les requêtes de données et encourager une saisie de données rapide et de haute qualité Documenter l’avancement du site et signaler tout risque ou problème à l’équipe clinique Contribuer au suivi du budget du site et veiller aux paiements rapides (le cas échéant) Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM et CTM
Requirements
- Based in Vancouver, BC Area
- Eligible to work in Canada without visa sponsorship
- A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experienced across multiple therapeutic areas, ideally including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
- A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
- Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- A clear communicator, problem-solver, and collaborative team player
- Willing and able to travel approximately 50% for on-site monitoring visits
Responsibilities
- Serve as the primary point of contact between investigational sites and the sponsor
- Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
- Ensure site compliance with ICH-GCP, SOPs, and Health Canada regulations
- Maintain up-to-date documentation in CTMS and eTMF systems
- Support and track site staff training and maintain compliance records
- Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
- Support subject recruitment and retention efforts at the site level
- Oversee drug accountability and ensure proper storage, return, or destruction
- Resolve data queries and drive timely, high-quality data entry
- Document site progress and escalate risks or issues to the clinical team
- Assist in tracking site budgets and ensuring timely site payments (as applicable)
- Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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What This Job Offers
Job Type
Full-time
Career Level
Senior
