Research Quality, Education & Compliance Specialist

The Research Quality Education & Compliance Specialist is an integral team member within the Office of Human Research Protections (OHRP) supporting research quality and excellence. Specifically the RQEC Specialist reporting to the OHRP Manager is responsible for coordinating the implementation of institutional standards and procedures for research studies and facilitation of activities aimed at enhancing and maintaining quality assurance and regulatory compliance at the Bloorview Research Institute (BRI). The RQEC Specialist also serves as a resource and support for clinical research teams. The role requires well-developed communication/organizational skills and advanced clinical research knowledge. The incumbent must be willing to work collaboratively and cooperatively with Scientists and research staff in a challenging and dynamic environment and will be responsible for the activities outlined below.

Summary of Duties but not limited to:

Support Research Operations within the Research Quality Education and Compliance program

• Develop and implement SOPs guidelines and other relevant tools and templates in collaboration with the OHRP Manager to support research activities in alignment with existing institutional processes and regulatory requirements
• Keep an up-to-date knowledge on ICH GCP institutional Health Canada and FDA regulations/policies applying appropriate implementation strategies for the Research Quality Education and Compliance program where required
• Provide consultation with investigators and research teams to address queries on research conduct and regulatory compliance
• Support regulated clinical trials teams in ensuring all trial processes are in accordance with guidelines as set forth by Health Canada ICH-GCP and applicable international regulatory authorities
• Review pertinent regulatory submissions for regulated BRI-Investigator initiated studies in accordance with institutional procedures
• Develop and deliver educational content for BRI research personnel training with a focus on regulatory compliance and best practices for the conduct of clinical research with consideration for onboarding professional development and emerging needs of research staff at BRI
• Provide resources to other research staff by identifying internal and external educational opportunities organizing community of practice meetings and delivering educational offerings driven by quality audit findings (e.g. forms and checklists educational training regulatory advice/consultation etc.) for Investigators and research staff
• Track metrics/data and manage records for intake Health Canada applications training monitoring activities education and training sessions
• Provide coordination/support for compliance and/or regulatory audits and inspections
• Monitor quality assurance of research projects at HB according to established framework
• Investigate identified quality issues brought forward by stakeholders on an ad-hoc basis
• Lead the resolution of quality issues through stakeholder engagement recommendations and support to the research teams involved and the environmental and regulatory scans to determine best practice
• Collaborate and communicate with other N2 and TAHSN quality assurance offices to share best practices and opportunities

As a champion of research quality you will work to promote a culture of quality in BRI by identifying and integrating safe best practices into daily activities to foster the delivery of exemplary research conduct.

The responsibilities described above are representative and are not to be construed as all-inclusive.

Qualifications/Skills:

• 2-5 years recent related clinical research management or regulatory experience with an understanding of Sponsor roles and responsibilities
• University degree in Health Sciences required
• Must have demonstrated experience with regulated clinical trials
• Must have advanced knowledge of the clinical research process and all associated regulations and guidelines such as Health Canada and FDA regulations Tri-Council Policy Statement (TCPS2) and ICH GCP
• Strong interpersonal skills and must be a team player
• Strong oral and written communication skills
• Strong analytical and problem-solving skills with good use of judgement and discretion
• Superior time management organizational skills accuracy and attention to detail
• Ability to multi-task prioritize work effectively and meet multiple deadlines
• Demonstrated proficiency in computer skills with strong skills in Microsoft office programs (MS Excel Word Power Point Outlook etc.) is required
• Experience using web-based programs and electronic research systems (e.g. REDCap SharePoint etc.) is a definite asset

Required Experience:

IC