Manager, Research Quality

5 days ago

Toronto, Canada St. Michael's Hospital Full time

The Applied Health Research Centre (AHRC) is an Academic Research Organization (ARO) at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, part of the Unity Health Toronto network, 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. Over the past ten years, 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 & Process (RQP)** is a member of the AHRC Management Team whose primary accountabilities are the:

- development, implementation, and maintenance of standard operating procedures (SOPs), processes, and guidelines relating to the clinical research activities and business operations at the AHRC
- establishment and adherence to the appropriate quality controls in all the AHRC’s clinical research activities
- oversight and performance of quality audits both internal and external to the AHRC
- oversight and assurance of appropriate staff training
- communication with internal and external contacts on quality and procedural issues

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**:

- Conduct routine review of existing systems and processes within the AHRC and its clinical research activities
- Conduct and oversee quality audits of research projects and study sites
- Review internal and external documentation to ensure completeness, consistency, and adherence to quality controls and institutional standards
- Develop policies, procedures, and standards for the AHRC in line with Health Canada (and other regulations, as needed), ICH/GCP, and/or hospital requirements as related to research quality and processes
- Lead and coordinate training of staff on policies, procedures and standards, in collaboration with the Manager of OEQRU, CTU, RIS, and Business Operations, related to research quality and research process
- Responsible for recruiting, hiring, developing, mentoring, training, supervising and evaluating (in conjunction with the Managers, OEQRU, CTRU, RIS, and Business Operations) all direct reports, research staff, and students employed by the AHRC
- Responsible for assigning and overseeing the workload of the Research Quality team
- Overall responsibility for all RQP project timelines and budgets; overall responsibility for strategic project planning and risk management of all RQP activities
- Contribute to establishing and maintaining relationships with research network partner sites

**QUALIFICATIONS**:

- MSc in related discipline with minimum 5 years related experience
- Recognized certifications (e.g. CCRP or PMP) are an asset
- 5+ years of clinical research experience (including monitoring and quality processes) with increasing responsibility
- 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

**_

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