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Clinical Site Auditor

2 months ago

Toronto, Ontario, Canada Parexel Full time

Aligning our values paves the way for limitless achievements.

The Clinical Site Auditor will oversee the integrity and quality of data while ensuring adherence to ICH GCP and local regulations at the site level. Monitoring activities will primarily be conducted virtually, supplemented by necessary on-site visits as outlined in the Study Monitoring Plan. The Clinical Site Auditor will work closely with the Site Manager to ensure that the site remains compliant with the study protocol and is prepared for inspections.

Educational Qualifications

A Bachelor's degree or RN in a relevant field, or an equivalent combination of education, training, and experience Proficiency in the local language is preferred; English proficiency is mandatory

Professional Experience

At least 12 months of experience as a clinical monitor, demonstrating experience in both virtual and on-site monitoring

Skills and Technical Proficiencies

Comprehensive knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory standards Strong computer skills with a willingness to adopt new technologies Exceptional communication, presentation, and interpersonal abilities Proven networking and relationship-building capabilities Effective communication skills with both internal and external stakeholders Adaptability to evolving technologies and processes