Quality Assurance Specialist

**About SickKids**:
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.

**Position Description**:
The Quality Assurance Specialist [QAS] (CRA/ Monitor) provides regulatory support, education and training for clinical research staff in alignment with the mission, vision, values, and goals of Clinical Research Operations.Part of the Regulatory and Compliance Office (RCO) at SickKids, and reporting to the Senior Manager, RCO, the QAS is responsible and accountable for the coordination, facilitation, guidance and evaluation of activities aimed to establish and maintain quality assurance and regulatory compliance of regulated clinical trials where SickKids is the regulatory Sponsor with Health Canada.

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.

Roles and responsibilities include: on behalf of SickKids as the study sponsor, conduct Site Initiation Visit, monitoring visits and study close out visits, ensuring that SickKids sponsored trials are run in compliance with ICH-GCP, Health Canada regulations and SickKids institutional SOPs and processes. Other responsibilities may include participating in other research and regulatory compliance initiatives, coordinating educational curricula, fostering development of teaching skills in others, performing educational needs assessment, delivery of clinical research specific orientation and onboarding, and facilitation of professional development. SOP development and process improvement work is also a key component of this role.

**Here¿s What You¿ll Get to Do**:

- Perform monitoring of clinical trials including site initiation visits (SIVs), first patient, and close out visits.
- Writing monitoring plans, risk assessments, and monitoring reports.
- Auditing activities to verify compliance and quality assurance, and report findings as per established processes.
- Promote and educate clinical researchers regarding the regulations, guidelines and best practices for the conduct of clinical research. This includes delivering in-person and virtual educational courses to clinical research staff.
- Write and disseminate Standard Operating Procedures (SOPs), templates, checklists, and other resources for clinical research staff.
- Facilitate Health Canada Sponsor and Site inspections.
- Perform other related duties as assigned by Sr. Manager, Regulatory and Compliance Office.

**Here¿s What You¿ll Need**:
Essentials
- Bachelor¿s degree required.
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP).
- A minimum of 5 years¿ experience in clinical research, including regulatory oversight of clinical trials
- Ability to use influence and negotiation skills to lead and collaborate on institutional projects.
- Experience with clinical trial monitoring and auditing.
- In-depth knowledge of Tri-Council Policy Statement (TCPS2), Good Clinical Practice, Health Canada Division 5.
- Experience developing new curricula and delivering presentations.
- Excellent organizational and time management skills.
- Strong written, verbal and analytical skills and the ability to manage multiple activities simultaneously.
- Ability to work collaboratively with colleagues and study teams.
- Customer service oriented with the ability to work well under pressure.
- Self-directed, detail oriented and enjoy working as a member of a team.
- Strong electronic data management skills and advanced skills in Microsoft Office programs.
- Demonstrated commitment and actions in advancing equity, diversity, and inclusion objectives.

Assets
- Master¿s degree preferred.
- Certification Quality Auditor from the American Society of Quality (ASQ) or equivalent.
- Clinical research experience within a university, research institute, or hospital research environment.
- Advanced degree in Health Sciences, Health Care Administrat