The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies.
Oversees all aspects of study site management to ensure patient safety is protected.
Provides guidance at the site and project level towards audit readiness standards.
Updates, tracks and maintains study specific trial management tools/systems, and status reports.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.
Requirements
Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
Minimum of 2 years of on-site monitoring experience; 1 year oncology and Phase I experience preferred
High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
Customer service demeanour; demonstrate flexibility and teamwork.
Ability to focus on detail for extended periods of time, high attention to accuracy.
Fluency in English communication, verbally and in writing.
Working knowledge of the drug development process.