CRA, Ontario

About This Role

Conduct site visits, monitor, and report on clinical trials as a Clinical Research Associate, ensuring operational excellence and compliance with ICH-GCP guidelines. This role involves building strong relationships with site staff and managing trial logistics.

Responsibilities

• 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
• Promote operational and scientific excellence
• Identify opportunities and best practices with local/regional partners
• Build and maintain solid and professional relationships with site staff
• Facilitate subject enrolment by incorporating recruitment strategies and action plans
• Maintain site audit/inspection readiness
• Ensure appropriate safety reporting and use of on-line safety review systems
• Verify electronic case report form data against source documentation
• Respond to site queries and escalate issues according to processes and timelines
• Conduct IP accountability and reconciliation
• Facilitate implementation of new technologies and systems at clinical sites
• Maintain site study supplies

Requirements

• 2+ years experience as a Clinical Research Associate
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
• Strong organizational and communication skills
• Fluent oral and written English language skills (including medical terms)
• Ability and willingness to travel up to 60%
• Working knowledge of common software packages
• Working knowledge of trial management databases and on-line systems

Qualifications

• Bachelor's degree in a scientific or healthcare-related field or nursing equivalent
• Minimum of 2 years of experience as a Clinical Research Associate; 1-2 years of clinical on-site monitoring experience

Nice to Have

• Experience in phase II and phase III trials
• Working knowledge of Electronic Data Capture
• Experience/working knowledge of the oncology disease area
• Experience of Centralized/Risk Based/Targeted monitoring
• Experience of working within a metric-based environment

Skills

* Required skills

Benefits