Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Senior Quality Assurance Associate
Location: Hybrid (Mississauga). 3 days per week in office, 2 days remote from home
Function: Quality Assurance
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- TMF Management: Perform regular quality checks on the Trial Master File (eTMF) to ensure completeness, accuracy, and contemporaneous filing of all study documents.
- Site-Level Compliance: Review site-level essential documents (e.g., Investigator Site Files, informed consent forms, protocol deviations) against established standard operating procedures (SOPs).
- Maintain up-to-date and in-depth knowledge of national and international GCP legislation, guidelines
- GCP Auditing: Conduct routine internal quality reviews and assessments to verify absolute adherence to ICH-GCP guidelines and regulatory requirements.
- Issue Resolution: Identify documentation errors or compliance gaps, log findings, and collaborate with clinical operations teams to implement corrective and preventive actions (CAPAs).
- Inspection Readiness: Assist in preparing study teams, investigator sites, and documentation for upcoming regulatory health authority inspections and formal audits
- Support onboarding of new hires.
- Manage workshops to support QMS and compliance awareness, Lessons Learned, etc.
- Provide advice regarding SOP, system and GCP questions of moderate complexity.
- Supports managing risk, including assessing root causes and developing effective actions to mitigate risk.
- Perform impact assessments of new/revised regulations, guidance, and standards.
This role is primarily aligned to Good Clinical Practices (GCP).
EDUCATION AND EXPERIENCE REQUIRED:
- Education: Bachelor’s degree in a life sciences discipline, healthcare, or a related field.
- Experience: Minimum of 2–4 years of experience in clinical research QA, clinical operations, or TMF management.
- GCP Expertise: Deep, practical understanding of ICH-GCP guidelines and FDA/global clinical trial regulations.
- Core Competencies: Exceptional attention to detail, strong problem-solving skills, and the ability to communicate compliance findings clearly to diverse project teams.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Full Time, Permanent
COMMITMENTS:
- Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
- Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
