Description
The Quality Assurance & Education (QA&E) arm of the Human Research Protections Program (HRPP) is part of Sunnybrook’s/Sunnybrook Research Institute’s (SRI’s) ongoing commitment to clinical research integrity and aims to raise the standard of clinical research and therefore, human research participant protection, through education, process improvements, internal research quality audits and regulatory compliance.
HRPP is seeking a highly motivated, experienced individual looking to expand their clinical research portfolio to join the team as a Coordinator, QA&E. The successful candidate will work closely within the HRPP department as well as with stakeholders throughout the institution.
Summary of Duties (not all encompassing):
- Act as a support/resource for compliant clinical research conduct at the institution
- Coordinate QA&E processes, including research quality reviews and internal research audits
- Coordinate, facilitate and track clinical research education initiatives and credentials
- Identify and facilitate compliance with clinical research training deficiencies
- Assist with the development and conduct of clinical research education and information sessions with a focus on regulatory compliance and best practices
- Identify and support needs from Sunnybrook’s clinical research community which may include at the onboarding and professional development stages, as needed
- Stay current and knowledgeable with changes in clinical research (i.e. regulations, guidelines, policies, procedures, practices, etc.)
- Develop, implement and maintain regulatory compliant clinical research related tools, templates, guidelines and procedures
- Provide coordination/support for compliance and/or regulatory audits and inspections
- Promote the use of Standard Operating Policies and Procedures for clinical research
- Maintain an up-to-date inventory of internal QA&E services
- Track metrics/data
- Engage and/or collaborate with external QA counterparts and/or stakeholders regarding clinical research practices
- Participate in and represent Sunnybrook/SRI at local, provincial and/or national related initiatives, as appropriate
Qualifications/Skills:
- Minimum 3 years recent related clinical research coordination/ethics and regulatory experience
- Post-graduate certificate in Clinical Research an asset
- University degree in Health Sciences required
- Auditing and/or monitoring experience an asset
- Demonstrated experience with Industry-sponsored and/or Investigator-Initiated regulated clinical trials required
- Advanced knowledge of clinical research processes, research ethics, and associated regulations and guidelines required
- Knowledge of clinical research processes at Sunnybrook/SRI an asset
- Strong interpersonal skills including excellent customer service work ethic and be a team player
- Strong oral and written communication skills
- Strong analytical and problem-solving skills including good judgement and discretion
- Professional, courteous, approachable manner
- Superior time management, organizational skills, accuracy and attention to detail
- Ability to multi-task, prioritize work effectively and meet multiple deadlines
- Demonstrated proficient computer skills with strong skills in Microsoft applications (i.e. Word, Excel, PowerPoint, Access, Outlook, etc.) required
- Experience using web-based programs and other electronic systems (e.g. REDCap, SharePoint, etc.) an asset
