CRA II, Ontario

CRA II, Remote, Ontario

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Research Associate, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out.
• Oversee and report on the conduct of clinical trials at a site level including online site visit reports and updates to electronic management systems.
• Promote operational and scientific excellence.
• Identify opportunities and best practices with local and regional partners to contribute to overall operational effectiveness.
• Facilitate subject enrolment incorporating recruitment strategies and action plans at site level.
• Maintain audit/inspection readiness at the site.
• Ensure appropriate safety reporting and use of online reporting systems such as Intralinks.
• Verify electronic case report form data against source documentation as per study schema and monitoring plan.
• Respond to site queries and escalating issues in accordance with processes and timelines.
• Conduct investigational product accountability and reconciliation.
• Facilitate implementation of new technologies and systems at clinical sites, such as electronic data capture and eSAE reporting.
• Maintain site study supplies.

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organizational and communication skills, with attention to detail.
• Fluent oral and written English language skills.
• Able and willing to travel up to 60% of the time or as per local requirements.
• Possession of a full driver’s license.
• Willing to work from a designated and appropriate home office as per local requirements.
• Competent computer skills and working knowledge of common software packages.
• Working knowledge of trial management databases and online systems.
• Able to attend a 1 week face‑to‑face in‑house training course as part of onboarding.
• Ability to work on multiple protocols/therapy areas.
• Experience in phase II and phase III trials (preferred).
• Experience with Electronic Data Capture (preferred).
• Experience in oncology disease area (preferred).
• Experience with centralized, risk‑based, or targeted monitoring (preferred).
• Experience working within a metrics‑based environment (preferred).
• Diplôme universitaire en sciences de la vie ou en soins infirmiers (équivalent d'un BA/BS/BSc).
• Certification d'infirmier(ère) autorisé(e) (RN) ou qualification académique/professionnelle équivalente.
• Expérience préalable en surveillance clinique sur site, généralement de 1 à 2 ans.
• Connaissance approfondie des Bonnes Pratiques Cliniques (BPC/ICH-GCP) et des réglementations locales.
• Compétences en communication orale et écrite en anglais, avec une maîtrise des termes médicaux.

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits that are designed to be competitive within each country and focused on well‑being and work‑life balance opportunities for you and your family.

Benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Program.
• Life assurance.
• Flexible country‑specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible…