Quality Assurance Specialist

Dedicated exclusively to children and their families, The Hospital for Sick Children (Sick Kids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading‑edge research and education. Our reputation would not have been built – nor could it be maintained – without the skills, knowledge and experience of the extraordinary people who come to work here every day.

Sick Kids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join Sick Kids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World.

Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.

The Regulatory and Compliance Office (RCO) at Sick Kids is dedicated to ensuring that all clinical research activities and institutional initiatives comply with national and international regulatory standards, ethical guidelines, and best practices. RCO oversees the development, activation, and management of Sick Kids‑Sponsored trials. The office leads quality assurance efforts, develops and maintains standard operating procedures (SOPs), and provides comprehensive training, education, and professional development opportunities for clinical research staff at Sick Kids, fostering a culture of integrity, safety, and compliance that underpins world‑leading pediatric care and research.

The Quality Assurance Specialist role within RCO provides operational support for clinical research staff, in alignment with the vision, goals and policies of Regulatory and Compliance office and the Research Institute. Reporting to the Quality Assurance Lead, the QAS is responsible and accountable for the coordination, facilitation, guidance and evaluation of activities aimed to establish and maintain quality assurance of clinical research  role requires well‑developed communication skills and advanced clinical research skills, particularly experience with regulated clinical trials.

The role collaborates with clinical investigators and research staff to ensure the safe, effective, and efficient conduct of clinical research.

• Development and implementation of standard operating procedures (SOPs), processes, guidelines and other pertinent tools and templates that reflect regulatory requirements for all clinical research activities at Sick Kids, with particular emphasis on the management and oversight of Sick Kids‑sponsored clinical trials.
• Creation and delivery of clinical research specific educational content in partnership with the Clinical Research Professional Development Specialists regarding the regulations, guidelines and best practices for the conduct of clinical research to support onboarding, and professional development of clinical research staff.
• Support the Clinical Research Project Manager(s)-Sponsor Oversight in the management of study start‑up activities for Sick Kids Sponsored clinical trials.
• Lead or support risk assessment activities and development of risk management plans.
• Develop risk‑based monitoring plan, and conduct monitoring activities for Sick Kids sponsored clinical trials to ensure continuous oversight and compliance with TCPS2, ICH‑GCP, Health Canada regulations and institutional SOPs and policies.
• Provide support to study teams in preparation, conduct, and preparation of responses to findings of any audit/inspection activities.
• Participate in other research and regulatory compliance initiatives under the direction of RCO leadership and in support of operational strategic objectives.

• Bachelor's degree required.
• Candidates should have at least 5 years of regulated clinical trials management experience, with a robust understanding of sponsor roles and responsibilities.
• Knowledge of Health Canada and FDA regulations, Tri‑Council Policy Statement (TCPS2) and ICH GCP is required.
• Strong analytical and problem‑solving skills,…