Clinical Research Associate, Bilingual
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Canada
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Tech Stack
About the role
- 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
- Build and maintain professional relationships with site staff
- Facilitate subject enrolment by implementing recruitment strategies and action plans at the site level
- Maintain site audit and inspection readiness
- Ensure appropriate safety reporting and use of online safety reporting/review systems such as Intralinks
- Verify data from electronic case report forms (eCRFs) against written and electronic source documentation
- Respond to site queries and escalate issues as necessary
- Conduct investigational product accountability and reconciliation
- Facilitate implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
Requirements
- 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 (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 online systems
- Experience in Phase II and Phase III trials (preferred)
- Experience/working knowledge of the oncology disease area (preferred)
Benefits
- Various annual leave entitlements
- A range of health insurance options 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 Program, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals 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, and more
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial processesICH-GCP guidelinesdata verificationeCRFsinvestigational product accountabilityrecruitment strategiessafety reportingElectronic Data CaptureeSAE reportingtrial management databases
Soft skills
organizational skillscommunication skillsattention to detailrelationship buildingproblem-solvingteam collaborationadaptabilitytime managementcritical thinkinginterpersonal skills