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Quality Assurance Specialist - Job Opportunity at The Hospital for Sick Children (SickKids)

Toronto, Canada
Full-time
Senior
Posted: February 9, 2025
Hybrid
CAD 85,000 - 105,000 per year based on Toronto market rates for senior QA roles in healthcare

Benefits

Comprehensive Healthcare & Dental Coverage
Professional Development Support
Work-Life Balance Focus
Staff Wellness Programs
Competitive Benefits Package

Key Responsibilities

Lead clinical trial monitoring and quality assurance activities
Develop and implement monitoring plans and risk assessments
Conduct site initiation visits and close-out procedures
Facilitate regulatory compliance and Health Canada inspections
Create and deliver clinical research training programs
Develop SOPs and process improvement initiatives

Requirements

Education

Bachelor's degree

Experience

5 years experience in clinical research

Required Skills

ICH-GCP knowledge Health Canada Division 5 expertise Advanced Microsoft Office skills Strong analytical capabilities Project management Curriculum development Communication and presentation skills Electronic data management

Certifications

SoCRA or ACRP certification required ASQ Quality Auditor certification (preferred)
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on pediatric clinical trials with specialized regulatory requirements Growing demand for quality assurance specialists in healthcare research Shift towards risk-based monitoring approaches in clinical trials Enhanced emphasis on digital documentation and remote monitoring capabilities

Role Significance

Typically part of a 5-10 person regulatory compliance team in major research hospitals
Senior individual contributor role with significant influence on research quality and regulatory compliance

Key Projects

Clinical trial monitoring program development Regulatory inspection preparation Quality management system implementation Staff training and development initiatives

Success Factors

Deep understanding of clinical research regulations Ability to influence without direct authority Strong documentation and process development skills Excellent stakeholder management capabilities Proactive problem-solving approach

Market Demand

High demand with steady growth projected due to increasing clinical trial complexity and regulatory requirements

Important Skills

Critical Skills

Regulatory compliance expertise - Essential for maintaining research integrity and legal compliance Clinical trial monitoring - Core function requiring detailed knowledge of GCP Communication skills - Critical for training delivery and stakeholder management

Beneficial Skills

Change management experience Risk assessment methodology Quality management systems expertise Educational program development

Unique Aspects

Specialized pediatric research environment
High-profile institution with international impact
Strong focus on professional development
Opportunity to influence healthcare outcomes

Career Growth

2-4 years in role before advancement, depending on organizational growth and individual performance

Potential Next Roles

Quality Assurance Manager Clinical Operations Director Regulatory Affairs Director Research Compliance Officer

Company Overview

The Hospital for Sick Children (SickKids)

World-renowned pediatric healthcare center with significant research operations

Leading pediatric hospital in Canada with strong international reputation
Major employer in Toronto's healthcare sector with significant research funding
Professional, research-focused environment with emphasis on excellence and innovation
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