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Cra Ii

2+ years
Not Disclosed
10 Oct. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.