Clinical Research Associate II (CRA II) – ICON plc
Location: Burlington (Remote – Ontario, Canada)
Job ID: JR136746
Portfolio: Clinical Monitoring – ICON Strategic Solutions
Work Type: Remote
Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.
Role Overview
The CRA II is responsible for overseeing clinical trial conduct at sites, ensuring compliance with regulatory requirements, and maintaining high operational standards. This includes site evaluation, initiation, monitoring, and close-out activities. The role emphasizes operational excellence, site relationship management, and accurate reporting.
Key Responsibilities
Site Management & Monitoring
Conduct clinical trial site visits: evaluation, initiation, monitoring, and close-out.
Oversee site conduct, including online site visit reports and updates to electronic management systems.
Build and maintain professional relationships with site staff.
Facilitate subject enrollment through recruitment strategies and action plans.
Maintain site audit/inspection readiness.
Ensure appropriate safety reporting using online safety systems (e.g., Intralinks).
Verify electronic case report form (eCRF) data against source documentation as per study plan.
Respond to site queries and escalate issues per process and timelines.
Conduct investigational product (IP) accountability and reconciliation.
Facilitate implementation of new technologies at clinical sites (EDC, eSAE reporting).
Maintain site study supplies.
Operational Excellence
Contribute to sponsor goals and promote operational and scientific excellence.
Identify opportunities and best practices with local/regional partners to improve operational effectiveness.
Required Education & Skills
Bachelor’s degree in scientific or healthcare-related field.
Minimum 2 years’ experience as a Clinical Research Associate.
In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and local regulations.
Trained CRA with on-site monitoring experience.
Strong organizational, communication, and attention-to-detail skills.
Fluent in English (oral and written).
Willingness to travel up to 60% or per local requirements.
Possession of a valid driver’s license.
Competent in computer skills and clinical trial management databases.
Able to work from a home office and participate in mandatory training sessions.
Preferred experience: Phase II/III trials, oncology, EDC systems, centralized/risk-based/targeted monitoring, metric-based environments.
Benefits
ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:
Annual leave entitlements
Health insurance for employees and families
Competitive retirement planning offerings
Global Employee Assistance Programme (LifeWorks – 24/7 access to specialized professionals)
Life assurance
Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)
More details: ICON Careers Benefits
Diversity & Inclusion
ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Reasonable accommodations are available: Request here
Application Encouragement
Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.
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