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