Quality Assurance Specialist
2 weeks ago
**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] provides regulatory support, education and training for clinical research staff in alignment with the mission, vision, values, and goals of Clinical Research Services and the Associate Chief, Clinical Research. 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 clinical trial 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: participating in 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.
**Here’s What You’ll Get to Do**:
- Perform monitoring of clinical trials including site initiation visits, 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.
**Here's What You'll Need**:
- Bachelor's Degree required.
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP).
- Certification Quality Auditor from the American Society of Quality (ASQ) or equivalent preferred.
- A minimum of 3 years’ experience in clinical research is required, 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.
- Clinical research experience within a university, research institute, or hospital research environment is considered an asset.
- Advanced degree in Health Sciences, Health Care Administration or another related field preferred.
**Employment Type: 1.0 FTE, Full-time, Permanent position. Hybrid position.**
**Our Commitment to Diversity**:
The children and families we care for are from a variety of communities, and so are our employees. We welcome and encourage everyone to join our organization and be part of our team.
Thank you for your interest in joining SickKids. Only those applicants selected for an interview will be contacted. In accordance with our Hospital policy, employment at SickKids is conditional upon the Hospital’s receipt of all necessary documentation.
**How to Apply
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