Clinical Research Associate - Oncology - Western Canada (Field-Based)

Pharmaceutical Research Associates, Inc; Winnipeg; On-site; CAD 70,000 - 90,000; Full time

Job summary

Join a leading clinical research organization as a Site Manager, overseeing site compliance and monitoring patient safety within clinical trials. The ideal candidate will possess 2+ years of on-site monitoring experience, ensuring collaboration and effective communication with various stakeholders.

Benefits

Various annual leave entitlements

Health insurance options for you and your family

Retirement planning options

Global Employee Assistance Programme

Flexible country-specific benefits

Qualifications

• Plus de 2 ans d'expérience en surveillance sur site dans l'industrie pharmaceutique ou CRO.
• Connaissance des normes ICH-GCP et des exigences réglementaires locales.
• Capacité de voyager environ 50% du temps pour des visites sur site.

Responsibilities

• Servir de point de contact principal entre les sites d'étude et le promoteur.
• Assurer la conformité du site aux réglementations et procédures.
• Soutenir le recrutement et la rétention des patients au niveau du site.

Skills

Communication

Résolution de problèmes

Travail d'équipe

Connaissance des réglementations de Santé Canada

Education

Bachelor’s degree in Life Sciences or equivalent

Tools

CTMS

eTMF

Job description

Overview

As a Site Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What You’ll Be Doing:

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct various 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 ensure high-quality, timely data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist in tracking site budgets and ensure timely payments (if 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 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, SOPs, et 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
• Superviser la gestion des médicaments, y compris leur entreposage, leur retour ou destruction
• Résoudre les requêtes de données et encourager une saisie 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
• Collaborer avec les partenaires interfonctionnels, incluant les CTA, LTM, et CTM

Qualifications

You are:

• Based in Western Canada, preferably 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, including Oncology, Hematology, Prostate Cancer, Lung Cancer, and Early Phase/Phase 1
• Holding 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

What ICON can offer you: Our success depends on the quality of our people. We’ve prioritized building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options for you and your family
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, with 24-hour access to support professionals
• Life assurance
• Flexible country-specific benefits, such as childcare vouchers, gym discounts, travel passes, and health assessments

Visit our careers website to learn more: https://careers.iconplc.com/benefits

ICON is committed to inclusion & belonging, providing an accessible environment for all candidates. We ensure equal opportunity employment without discrimination. If you require a reasonable accommodation during the application process, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for.