Join Sitero as a Senior Quality Assurance Associate, blending hybrid work in Mississauga with essential GCP compliance and TMF management expertise. Ensure adherence to regulatory standards while supporting quality in clinical trials. This full-time role focuses on quality assurance compliance across multiple therapeutic areas.
Ideal candidates will have 2-4 years of experience in clinical research QA or TMF management, utilizing their understanding of ICH-GCP guidelines to maintain quality during studies. You will also assist in preparing teams for inspections and promote compliance awareness. Key Responsibilities:
- Perform regular quality checks on the Trial Master File (eTMF)
- Review site-level essential documents for compliance
- Conduct internal quality reviews adhering to ICH-GCP
- Identify documentation errors and implement CAPAs
- Assist in preparing for regulatory inspections Requirements:
- Bachelor’s degree in life sciences or a related field
- 2-4 years of clinical research QA experience
- Deep understanding of ICH-GCP guidelines
- Exceptional attention to detail and problem-solving skills
- Solid communication skills for compliance findings Drive quality assurance and compliance initiatives at Sitero, contributing to innovative clinical solutions.