CRA II

ICON is looking for a Clinical Research Associate to monitoring studies in the Greater Toronto area! 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)