CRA II, Ontario

Join to apply for the CRA II, Ontario role at ICON Strategic Solutions (Remote, Ontario) – Be among the first 25 applicants!

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.

What You Will Be Doing

• 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
• Contribute to sponsor goals
• Promote operational and scientific excellence
• Identify opportunities and best practices with local/regional partners to contribute to overall operational effectiveness
• Build and maintain solid and professional relationships with site staff
• Facilitate subject enrolment incorporating recruitment strategies and action plans at site level
• Maintain site audit/inspection readiness
• Ensure appropriate safety reporting and use of online safety reporting/reviewing systems such as Intralinks
• Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
• Respond to site queries and escalating issues in accordance with processes and timelines
• Conduct IP accountability and reconciliation
• Facilitate implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
• Maintenance of site study supplies

Your profile

• 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.
• BA/BS/BSc in the sciences or nursing equivalent.
• A trained CRA with on-site monitoring experience.
• Comprehensive knowledge and understanding of ICH-GCP.
• Fluent oral (face‑to‑face and telephone) 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.
• Able and willing to work from a designated and appropriate home office as per local requirements.
• Willing to attend and contribute to team meetings including mandatory training (remote/off‑site).
• Competent computer skills including working knowledge of common software packages.
• Working knowledge of trial management databases and on‑line systems.
• Able to attend a 1‑week face‑to‑face in‑house training course as part of on‑boarding training.
• Able and willing to work on several protocols/therapy areas.
• Experience in phase II and phase III trials (preferred).
• Working knowledge of Electronic Data Capture (preferred).
• Experience/working knowledge of the oncology disease area (preferred).
• Experience of Centralized/Risk Based/Targeted monitoring (preferred).
• Experience of working within a metric‑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.

What ICON Can Offer You

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being
• Life assurance
• Flexible country‑specific optional benefits, including 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 environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Referal increase your chances of interviewing at ICON Strategic Solutions by 2x.

Get notified about new Clinical Research Associate jobs in Canada .

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing