Quality Assurance Specialist

4 months ago


Toronto, Canada SickKids Full time

**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**:
**Quality Assurance Specialist - Clinical Trial Support Unit, Division of Hematology-Oncology**

Under the supervision of the Hematology-Oncology Clinical Trial Support Unit (CTSU) Manager, the Quality Assurance Specialist (QAS) will enhance CTSU¿s capability and capacity for high quality clinical research by identifying, supporting, expanding and implementing opportunities for compliance, risk management, and dissemination of best practices and current information in the field of research quality assurance (QA). The individual will provide guidance to the CTSU Clinical Research Associates (CRAs) and researchers to manage QA activities.

The role requires well-developed communication skills and advanced clinical research skills, particularly experience with regulated clinical trials. The role collaborates with CRAs, clinical investigators and research staff to ensure the safe, effective, and efficient conduct of clinical research within the CTSU.

**Here's What You'll Get to Do**:

- Perform monitoring of clinical trials including first patient, and close out visits.
- Auditing activities to verify compliance and quality assurance, and report findings as per established SickKids processes.
- Promote and educate CRAs and clinical researchers regarding the regulations, guidelines and best practices for the conduct of clinical research.
- Write and disseminate Standard Operating Procedures (SOPs), templates, checklists, and other resources for clinical research staff.
- Establishes a CTSU tracker/database for collecting data and generating reports and highlighting metrics on research performance

**Here's What You'll Need**:
**Essential Requirements**
- Bachelor's Degree required.
- A minimum of 3 years experience in clinical research is required, including regulatory oversight of clinical trials
- Experience with clinical trial monitoring and auditing.
- In-depth knowledge of Tri-Council Policy Statement (TCPS2), Good Clinical Practice, Health Canada Division 5.
- 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.
- 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**
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP) preferred.
- Clinical research experience within a university, research institute, or hospital research environment is considered an asset.

**Here's What You'll Love**:
**Benefits**
- This position is eligible for employee benefits coverage; including health and dental. The full benefits offered will be discussed at the time of position offer.
- A focus on employee wellness with our new Staff Health and Well-being Strategy. Self-care helps us support others.

**Impact**
- A hospital that welcomes and focuses on Equity, Diversity, and Inclusion.
- The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World.

**Employment Type**
- Permanent full time: 35-hour work week, hybrid option

**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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