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Senior Cra

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

Senior Clinical Research Associate (CRA) – ICON plc

Location: Burlington, Ontario, Canada (Remote)
Job ID: JR135305
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 Senior CRA is responsible for conducting, overseeing, and reporting on clinical trial site activities. This includes site evaluation, initiation, monitoring, and closeout, ensuring trials comply with regulatory requirements and ICH-GCP guidelines.


Key Responsibilities

Site Management & Monitoring:

  • Conduct clinical trial site visits: evaluation, initiation, monitoring, and closeout.

  • Oversee site operations and report findings via online site visit reports and electronic management systems.

  • Build and maintain professional relationships with site staff.

  • Facilitate patient enrolment, including recruitment strategies and site-specific action plans.

  • Maintain site audit/inspection readiness.

  • Ensure proper safety reporting using online systems such as Intralinks.

  • Verify eCRF data against written and electronic source documentation.

  • Respond to site queries and escalate issues according to processes and timelines.

  • Conduct Investigational Product (IP) accountability and reconciliation.

  • Support implementation of new technologies and systems 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 enhance overall operational effectiveness.


Required Education & Experience

  • Bachelor’s degree in a scientific or healthcare-related field (BA/BS/BSc in sciences or nursing equivalent).

  • Minimum 2 years of CRA experience with on-site monitoring exposure.

  • In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.

  • Experience in Phase II and III trials preferred.

  • Working knowledge of Electronic Data Capture systems preferred.

  • Oncology experience preferred.

  • Experience in Centralized/Risk-Based/Targeted monitoring preferred.

  • Experience in metric-driven environments preferred.

  • Fluent oral and written English.

  • Ability and willingness to travel up to 60%.

  • Possession of a full driver’s license.

  • Competent computer skills and familiarity with trial management databases.


Skills & Competencies

  • Strong organizational, analytical, and communication skills.

  • Attention to detail and ability to manage multiple protocols/therapy areas.

  • Ability to maintain professional relationships with site personnel.

  • Proactive problem-solving and escalation skills.


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

  • 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

Candidates are encouraged to apply even if they don’t meet all listed requirements, as they may still be a strong fit for ICON roles.