Senior Quality Assurance Associate

Sitero LLC•Markham, ON

10d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a life sciences discipline, healthcare, or a related field.
Minimum of 2–4 years of experience in clinical research QA, clinical operations, or TMF management.
Deep, practical understanding of ICH-GCP guidelines and FDA/global clinical trial regulations.
Exceptional attention to detail, strong problem-solving skills, and the ability to communicate compliance findings clearly to diverse project teams.

Responsibilities

Perform regular quality checks on the Trial Master File (eTMF) to ensure completeness, accuracy, and contemporaneous filing of all study documents.
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
Conduct routine internal quality reviews and assessments to verify absolute adherence to ICH-GCP guidelines and regulatory requirements.
Identify documentation errors or compliance gaps, log findings, and collaborate with clinical operations teams to implement corrective and preventive actions (CAPAs).
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.