Senior Clinical Research Associate - Oncology/Cross TA - (Toronto / Field Based)

ICON

  • Toronto, ON
  • Permanent
  • Full-time
  • 2 months ago
OverviewAs a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.En tant qu’ARC (Associé(e) de recherche clinique), vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, propulsée par l’intelligence en santé.ResponsibilitiesWhat 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
QualificationsYou are:
  • Based in Toronto Canada
  • 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
  • Oncology monitoring experience is required
  • 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 Toronto canadien
  • Autorisé(e) à travailler au Canada sans parrainage de visa
  • Un(e) professionnel(le) de la recherche clinique avec plus de 3 ans d’expérience en surveillance sur site dans l’industrie pharmaceutique ou auprès d’une CRO
  • Une experience de la surveillance de l'oncologie est requise
  • 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:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
  • 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

ICON