Manager Research Quality Patient Engagement & Registries (Job ID: 4294)
The Applied Health Research Centre (AHRC) is an Academic Research Organization (ARO) within Unity Health Toronto, a network of three hospitals based in Toronto, with expertise in clinical study design, study coordination, and biostatistics. The AHRC has experience managing more than 200 multi-centre, national and international clinical trials, observational studies, and qualitative studies. It employs industry-leading web-based secure database technology, which incorporates advanced data validation and reporting tools. The AHRC has grown to be one of the largest AROs in Canada, and partners with diverse groups including the Toronto Academic Health Science Network (TAHSN), the Mayo Clinic, and Ontario SPOR Support Unit (OSSU).
The Manager, Research Quality, Patient Engagement & Registries (QPR), is a member of the AHRC Management Team, whose primary accountabilities are:
- Management of research activities occurring in the unit and providing clinical research expertise to clinicians and staff conducting large-scale registry studies, qualitative research, patient engagement and ensuring research quality processes.
- Services include: multi-site project management, site training and oversight, protocol development and writing, research ethics submissions, methodological consultation, database build, data management, data analysis, qualitative research methodologies and project oversight, clinical trial monitoring and audits, patient and community engagement in research, knowledge translation.
- Development, implementation, and maintenance of standard operating procedures (SOPs), processes, and guidelines in line with Health Canada (and other regulations, as needed), ICH/GCP, and/or hospital requirements as related to research quality and processes.
- Oversight and performance of quality research audits both internal and external to the AHRC.
- Oversight and assurance of appropriate staff training.
This position requires the ability to have a deep understanding of clinical research in general, research processes, and local and national regulatory requirements, and the ability to adapt industry and commercial best practices to an academic environment that is congruent with the AHRC's mission and values. The incumbent must be flexible to work beyond the job description at times as work demands.
DUTIES & RESPONSIBILITIES:
Managerial:
- Conduct routine review of existing systems and processes within the AHRC and its clinical research activities
- Review internal and external documentation to ensure completeness, consistency, and adherence to quality controls and institutional standards
- Lead and coordinate training of staff on policies, procedures and standards, in collaboration with the AHRC Leaders, related to research quality and research process
- Responsible for recruiting, hiring, developing, mentoring, training, supervising and evaluating all direct reports, research staff, and students
- Contribute to establishing and maintaining relationships with research network partner sites
- Providing methodological and operational input to study protocols and grant applications that will be managed by the AHRC
- Risk management activities for the AHRC including proactive risk identification and management to minimize exposure to risk, in collaboration with the AHRC Leaders
- Involved in the review of all confidentiality statements, legal disclosures, and legal documents
- Ensure that the AHRC's quality and process 'systems' are keeping pace with regulatory requirements
- Ensures financial and planning processes are appropriately linked to projects, service delivery and other visible department outputs which provide value to clients, while identifying opportunities for cost savings and revenue generation
- Contributes to RFP responses, professional publications, presentations, and posters
Administrative:
- Overall responsibility for all project timelines and budgets; overall responsibility for strategic project planning and risk management of all research unit activities
- Associated scheduling functions such that staffing is maintained at efficient and optimal levels (including daily, vacation, and sick time coverage)
- Approving expenditures, within signing authority limits
- Conducts administrative and technical research for studies that are or will be managed by the AHRC
QUALIFICATIONS:
- At least a Master's degree in a health-related discipline
- Recognized certifications (e.g. CCRP or PMP) are an asset
- 5 years of clinical research experience (including monitoring and quality processes) with increasing responsibility
- Experience managing large registry studies and qualitative studies
- Experience managing research teams, including staff that conduct internal and external monitoring
- Strong understanding of ICH/GCP guidelines, and the Canadian and US regulatory environments
- Knowledge of privacy legislation (such as PIPEDA, PHIPA, US HIPAA) as it relates to the conduct of clinical research
- Ability to understand and interpret complex clinical study protocols
- Detail-oriented and highly meticulous, even when faced with competing priorities in a fast-paced work environment
- Ability to identify challenges, manage expectations, and take the initiative to identify solutions
- Demonstrated leadership with the ability to work collaboratively in a team environment
- Strong interpersonal capabilities to build and maintain networks, and to communicate effectively with diverse people in different settings
- Excellent communication skills, both written and verbal
- Willingness and ability to travel within and outside of Canada
- The ability to direct the work and foster the learning and development of others