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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.
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%.
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.
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
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
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
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.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
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.
Salary Range
$108,576.00-$135,720.00Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
