Quality Assurance Specialist

SickKids; Old Toronto; Hybrid; CAD 70,000 - 110,000; Full time

Job summary

An established industry player in pediatric healthcare is seeking a Quality Assurance Specialist to enhance clinical research operations. In this pivotal role, you will ensure compliance with regulatory standards, conduct site visits, and provide essential training to research staff. Your contributions will directly impact the quality of care for children, fostering an environment of excellence and innovation. Join a dedicated team committed to advancing health outcomes and making a meaningful difference in the lives of families. This is a unique opportunity to work in a supportive environment that values equity, diversity, and inclusion.

Benefits

Health benefits

Dental benefits

Employee wellness programs

Qualifications

• 5+ years of experience in clinical research with regulatory oversight.
• Ability to develop curricula and deliver presentations.

Responsibilities

• Conduct monitoring visits and ensure compliance with regulations.
• Write monitoring plans and standard operating procedures.

Skills

Clinical research skills

Regulatory compliance

Communication skills

Organizational skills

Negotiation skills

Data management skills

Analytical skills

Customer service orientation

Education

Bachelor's degree

Master's degree (asset)

Tools

Microsoft Office

Job description

Quality Assurance Specialist

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Job ID

22069

Location

Toronto, Ontario

FTE

1.00

Hours of Work

35.00

Dept/Program Name

RQRM

Contract Length

Date Posted

2025-02-07

Deadline to Apply

2025-02-17

Target Openings

1

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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 Operations. As a member 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:

• Bachelor¿s degree.

• 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.

Asset

• Master¿s degree.

• Clinical research experience within a university, research institute, or hospital research environment.

• Advanced degree in Health Sciences, Health Care Administration or another related field.

• Certification Quality Auditor from the American Society of Quality (ASQ) or equivalent.

Here¿s What You¿ll Love

Benefit

• This position is eligible for employee benefits coverage; including but not limited to, health and dental benefits. The 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: 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.

When requested, SickKids will provide access and inclusion supports to eligible candidates to support their full engagement during the interview and assessment process. Information received related to access or inclusion will be addressed confidentially.

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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