Senior Clinical Research Associate

Job summary

Serve as the primary contact between investigational sites and sponsors while conducting all types of site visits. Ensure site compliance with ICH-GCP and Health Canada regulations while managing data quality and patient safety reporting.

Job details

Senior Clinical Research Associate - Oncology/Multi TA - Vancouver 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 * 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 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 Vous êtes: * Basé(e) dans la région du Vancouver, BC * 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 * 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 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: * 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 Benefits may vary depending on role and location. Visit our careers site [https://careers.iconplc.com/benefits] to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here [https://careers.iconplc.com/reasonable-accommodations]. Salary Range $108,576.00-$135,720.00 Are you a current ICON Employee? Please click here [https://wd3.myworkday.com/icon/d/task/1422$1235.htmld] to apply

What you’ll do

Serve as the primary contact between investigational sites and sponsors while conducting all types of site visits. Ensure site compliance with ICH-GCP and Health Canada regulations while managing data quality and patient safety reporting.

Requirements

Requires a Bachelor's degree in Life Sciences or RN qualification and over 3 years of on-site monitoring experience in pharma or CRO. Must be proficient in ICH-GCP and clinical systems, with a willingness to travel approximately 50%.

Benefits

• Competitive Base Salary • Performance Related Incentives • Medical Coverage • Dental Coverage • Vision Coverage • Retirement And Pension Plans • Life Assurance • Disability Coverage • Employee Assistance Programmes • Wellbeing Resources • Learning And Development Opportunities

Listed skills

• Problem solving · Preferred
• Regulatory Compliance · Preferred
• Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• On-site Monitoring
• ICH-GCP
• CTMS
• eTMF
• Patient Safety Monitoring
• Drug Accountability
• Site Management
• Regulatory Compliance
• Clinical Trial Documentation
• Subject Recruitment
• Problem Solving
• Collaboration

Job areas

• Healthcare
• Science & Research