- Toronto, Ontario, Canada
- On-site
- Full-time · Entry
- CA$70K–CA$88K per year
- 2+ years
The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol activation and follow up to trial closure.
Responsibilities
- Monitoring and promoting the quality and integrity of data, recording clinical trial data in case report forms (CRFs).
- Compilation of ethics and regulatory documents.
- The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and depar guidelines and professional standards of practice.
- Data is assessed, compiled, recorded and submitted to pharmaceutical companies or used for internal studies.
- Ensure all data is complete, accurate, timely and must be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations.
Requirements
- Bachelor’s degree in a health or science-related discipline
- Nice to have: Clinical Research Graduate Certificate