ICON is looking for a Clinical Research Associate in Canada!! Rare Disease & Oncology experience is preferred!!
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 and on-line site visit reports and updates to electronic management systems
Proactive site management including:
Building and maintaining solid and professional relationships with site staff
Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
Maintaining site audit/inspection readiness
Ensuring appropriate safety reporting and use of on-line 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
Responding to site queries and escalating issues in accordance with processes and timelines
Conducting IP accountability and reconciliation
Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
Maintenance of site study supplies
Operational Excellence:
Contribute to sponsor goals
Promote operational and scientific excellence
Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.
You are:
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)
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