Clinical Research Associate - Oncology - Western Canada (Field-Based)
ICON
As a Site Manager you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
En tant que gestionnaire de site, vous vous joindrez à la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en soins de santé.
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
• Maintenir 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
You are:
- Based in Western Canada, with a preference for candidates located in British Columbia or Alberta
- Eligible to work in Canada without visa sponsorship
- A clinical research professional with 2+ 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
Vous êtes:
- Basé(e) dans l’Ouest canadien, idéalement en Colombie-Britannique ou en Alberta
- Autorisé(e) à travailler au Canada sans parrainage de visa
- Un(e) professionnel(le) de la recherche clinique avec plus de 2 ans d’expérience en surveillance sur site dans l’industrie pharmaceutique ou auprès d’une CRO
- Expérimenté(e) dans plusieurs aires thérapeutiques, idéalement en oncologie, hématologie, cancer de la prostate, cancer du poumon et en phases précoces / Phase 1
- Titulaire d’un baccalauréat en sciences de la vie ou d’un diplôme équivalent, ou infirmier(ère) autorisé(e) (IA)
- Connaissant bien les règlements de Santé Canada et le travail avec les comités d’éthique de la recherche (CER)
- Maîtrisant les ICH-GCP, les exigences réglementaires locales et les systèmes cliniques comme le CTMS et le eTMF
- Un(e) communicateur(trice) clair(e), apte à résoudre des problèmes et collaboratif(ve) au sein d’une équipe
- Prêt(e) et capable de voyager environ 50 % du temps pour des visites de surveillance sur site
What ICON can offer you:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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