Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) 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. SickKids 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 SickKids, 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 SickKids 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 SickKids-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 SickKids, 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 at SickKids. The 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.

Here’s What You’ll Get To Do

- 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 SickKids, with particular emphasis on the management and oversight of SickKids-sponsored clinical trials.
- Creation and delivery of clinical research specific educational content in partnership with the Clinical Research Career 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 SickKids 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 SickKids 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.

Essential Requirements

Here’s what you’ll need

- 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, with the ability to assess complex regulatory issues and develop strategic solutions.
- Experience with clinical trial monitoring and auditing
- Excellent organizational and time management skills and the ability to manage multiple activities simultaneously.
- Strong written, verbal, and presentation skills.
- Demonstrated initiative, excellent use of judgment and discretion.
- Excellent people skills and stakeholder management skills.
- Self-directed, meticulous and enjoy working independently and as a member of a team.
- Strong electronic data management skills and advanced skills in Microsof

📌 Quality Assurance Specialist (Toronto)
🏢 The Hospital for Sick Children
📍 Toronto