Quality Assurance SpecialistThe Hospital for Sick Children • Toronto, Ontario, Canada
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Quality Assurance Specialist
The Hospital for Sick Children
- Toronto, Ontario, Canada
- Toronto, Ontario, Canada
À propos
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.
The Regulatory and Compliance Office (RCO) at SickKids is dedicated to ensuring that all clinical research activities and institutional initiatives comply with national and international regulatory standards, ethical guidelines, and best practices. RCO oversees the development, activation, and management of SickKids- Sponsored trials. The office leads quality assurance efforts, develops and maintains standard operating procedures (SOPs), and provides comprehensive training, education, and professional development opportunities for clinical research staff at SickKids, fostering a culture of integrity, safety, and compliance that underpins world-leading pediatric care and research.
The Quality Assurance Specialist role within RCO provides operational support for clinical research staff, in alignment with the vision, goals and policies of Regulatory and Compliance office and the Research Institute. Reporting to the Quality Assurance Lead, the QAS is responsible and accountable for the coordination, facilitation, guidance and evaluation of activities aimed to establish and maintain quality assurance of clinical research at SickKids. 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.
Here's What You'll Get To Do
Development and implementation of standard operating procedures (SOPs), processes, guidelines and other pertinent tools and templates that reflect regulatory requirements for all clinical research activities at SickKids, with particular emphasis on the management and oversight of SickKids-sponsored clinical trials.
Creation and delivery of clinical research specific educational content in partnership with the Clinical Research Professional Development Specialists regarding the regulations, guidelines and best practices for the conduct of clinical research to support onboarding, and professional development of clinical research staff.
Support the Clinical Research Project Manager(s)-Sponsor Oversight in the management of study start-up activities for SickKids Sponsored clinical trials.
Lead or support risk assessment activities and development of risk management plans.
Develop risk-based monitoring plan, and conduct monitoring activities for SickKids sponsored clinical trials to ensure continuous oversight and compliance with TCPS2, ICH-GCP, Health Canada regulations and institutional SOPs and policies.
Provide support to study teams in preparation, conduct, and preparation of responses to findings of any audit/inspection activities.
Participate in other research and regulatory compliance initiatives under the direction of RCO leadership and in support of operational strategic objectives.
Essential Requirements
Here's What You'll Need:
Bachelor's degree required.
Candidates should have at least 5 years of regulated clinical trials management experience, with a robust understanding of sponsor roles and responsibilities.
Knowledge of Health Canada and FDA regulations, Tri-Council Policy Statement (TCPS2) and ICH GCP is required.
Strong analytical and problem-solving skills, with the ability to assess complex regulatory issues and develop strategic solutions.
Experience with clinical trial monitoring and auditing
Excellent organizational and time management skills and the ability to manage multiple activities simultaneously.
Strong written, verbal, and presentation skills.
Demonstrated initiative, excellent use of judgment and discretion.
Excellent people skills and stakeholder management skills.
Self-directed, meticulous and enjoy working independently and 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.
Preferred Requirements
Advance degree (Master's or PhD) in Health Sciences, Health Care Administration or another related field.
Current Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP) certification, or Certified Quality Auditor from the American Society of Quality (ASQ-or equivalent)
Clinical research experience within a university, research institute, or hospital research environment.
Proficiency in written and spoken French.
Benefits
Here's What You'll Love:
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.
For more on why you'll love working at SickKids, visit our careers site.''
Employment Type
Full-time permanent position.
Hybrid position. ( ~2 days per week on site or more, if needed. Subject to change in the future.)
SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.
If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.
Technical difficulties? Email with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.
Tip: Combine your cover letter and resume into ONE document of 20 pages or less as you cannot upload multiple documents as part of your application.
Every application is reviewed by a human recruiter and all hiring decisions are made by people. In some cases, AI-assisted tools are used to help review applications based on job-related qualifications.
All positions posted on the SickKids Hospital's Careers Site represent current vacancies, unless otherwise posted in the job description.
Compétences linguistiques
- English
Avis aux utilisateurs
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