Quality Assurance Lead, Clinical Research – Clinical Research Operations, at the Hospital for Sick Children

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

SickKids’ Clinical Research Operations (CR Ops) is seeking a dynamic and highly motivated Quality Assurance Lead, Clinical Research with experience and expertise in clinical research quality assurance program development and oversight. As SickKids embarks on a transformative journey in support of Precision Child Health (PCH), we are dedicated to building a robust Clinical Research Quality Assurance program within the Regulatory and Compliance Office (RCO) to ensure comprehensive institutional support and oversight, streamlined processes, and standardized SOPs for conducting innovative, high-quality, and safe investigator-initiated clinical trials at SickKids.

In this pivotal role, within the Regulatory and Compliance Office which oversees investigator-initiated clinical trials at SickKids, you will be responsible for developing and implementing standardized operating procedures (SOPs), processes, guidelines, and other pertinent tools to be utilized by the Office and study teams throughout SickKids. You will also be responsible for overseeing the monitoring function of the CRO, as well as closely collaborating with the Education and Training function, ensuring development of a robust training and education program for study investigators and coordinators across the institution. This role will also be collaborating with the Audit and Compliance Lead, in the development of a clinical research audit and compliance program at SickKids.

To excel in this position, the Quality Assurance Lead, Clinical Research must possess in-depth knowledge of regulations, guidelines, and best practices governing clinical trials, along with a keen understanding of the evolving landscape of clinical research and the regulatory requirements for new drugs, medical devices, gene therapies and more. This role will be instrumental in the development and implementation of high-quality SOPs and processes and a robust quality assurance program to promote the safe, effective, and efficient conduct of clinical trials at SickKids.

Here’s What You’ll Get to Do: 

• Under the leadership of the Senior Manager, Regulatory and Compliance Office, develop, implement, and manage the Quality Assurance program for investigator-initiated trials at SickKids
• Develop, review, and implement Standard Operating Procedures (SOPs) and processes related to IIT sponsor oversight activities, ensuring compliance with GCP, regulatory standards and best practices
• Provide guidance and support to study monitors and other CRS staff to ensure IITs meet internal sponsor oversight program policies, SOPs and relevant requirements
• Help develop and implement processes that reflect regulatory requirements for all clinical trials with a specific focus on the management and oversight of SickKids-sponsored investigator-initiated clinical trials
• Closely collaborate with Audit and Compliance Lead to help establish an Audit and Compliance program for clinical research at SickKids
• Provide regulatory guidance and support to cross-functional teams throughout the clinical trial lifecycle, including regulatory submissions, trial activation, trial conduct, and audits and inspections
• Function as consultant/support for Research IT and other relevant departments on implementation of clinical research processes and technologies that follow regulatory requirements (e.g., implementation of a validated data management solution for IITs)
• Function as consultant/expert to researchers and RI leadership related to regulatory-, audits- and inspections-related questions for regulated clinical trials. Provide assistance for study teams during external federal inspections
• Actively review and interpret regulatory guidelines and updates to ensure SickKids is compliant with evolving regulatory requirements in Canada and internationally
• Partner with researchers and study monitors to develop corrective actions to address audit findings and oversee implementation of corrective actions
• Develop and maintain templates and resources to guide clinical research staff in the conduct of clinical research to facilitate regulatory compliance
• Collaborate with internal stakeholders, including investigators, research coordinators, and administrators, to ensure uptake and compliance with regulatory requirements and institutional policies
• Identify opportunities for process improvement and optimization, leading initiatives to enhance efficiency and effectiveness in regulatory affairs and clinical trial management
• Conduct regulatory intelligence activities to assess the regulatory landscape and anticipate potential impact on clinical research programs and initiatives at SickKids
• Assist the education team and the Office of Clinical Research Professionals (OCRP) with the development of relevant education and training materials, including iLearns and workshops for effective training and knowledge dissemination
• Partner with the Office of Clinical Research Professionals (OCRP) and education and training team to ensure SickKids maintains a qualified workforce of clinical research professionals
• Escalate issues, risks and opportunities to senior leadership, as needed
• Liaison with Health Canada on behalf of Clinical Research Operations, when needed
• Provide leadership and direction to staff including, coaching, advising, mentoring and communicating and educating staff to ensure a complete understanding of business and department strategy, programs and related legislation. Responsible for the recruitment, performance management, and development of staff
• Represent SickKids on relevant committees and through presentations, where appropriate
• Perform other related duties as assigned by Director and other senior CRS leaders

Here’s What You’ll Need:  

Essential Requirements

• Minimum of a Bachelor’s degree in a research, life sciences, health sciences or related field is required
• A minimum of 5 years experience in clinical research is required, including a combination of either:
  • 2+ years of quality assurance, regulatory affairs, and/or audits within the pharmaceutical, biotechnology, or academic research environment, and/or; 
  • 3+ years of experience coordinating and managing regulated clinical trials
• 2+ years experience in developing and implementing SOPs and processes related to regulatory affairs and clinical trials management is required
• Knowledge of Health Canada and FDA regulations, Tri-Council Policy Statement (TCPS2) and ICH GCP is required
• Excellent organizational, communication, problem-solving and interpersonal skills, high degree of accuracy and attention to detail
• Strong analytical and problem-solving skills, with the ability to assess complex regulatory issues and develop strategic solutions.
• Excellent organizational and time management skills
• Strong written, verbal, and analytical skills and the ability to manage multiple activities simultaneously
• 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

Assets

• Advanced degree in Health Sciences, Health Care Administration, or another related field is an asset
• Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP) is a strong asset
• Experience in pharmaceutical/biotechnology industry is an asset
• Experience with auditing or inspection activities is an asset
• Formal people management experience is a strong asset

Here’s What You’ll Love:

Benefits

• 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:   

• 35-hour work week
• Three-year contract with benefits, with opportunity for extension
• Hybrid (Onsite and Remote) Work Model – necessary technology provided for remote work

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

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.

If you are still experiencing technical difficulties please email ask.hr@sickkids.ca to send us a short description of the issues you are experiencing. Please note that we will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.