Clinical Research Manager - Cardiovascular Outcomes Research Program

Women's College Hospital - Toronto, ON (30+ days ago)

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The Cardiovascular Outcomes Research Group at Women’s College Hospital is a dynamic, forward thinking program led by Dr. Jacob (Jay) Udell that works closely with the Peter Munk Clinical Trials and Translation Unit at Toronto General Hospital, the Applied Health Research Centre at St. Michael’s Hospital and the CANHEART research group at ICES, all based within the University of Toronto. The group has expertise in national and international observational studies, clinical trials, and health services research in primary and secondary cardiovascular risk prevention. Our work on innovative cardiovascular risk factor identification and therapy has led to: clinical trial and outcomes publications in the New England Journal of Medicine, JAMA, Circulation, JACC, CMAJ, and Lancet Diabetes; alterations in international cardiovascular practice guidelines; and changes by the FDA in the label of diabetes drugs. Utilizing the administrative health care databases, registries, and clinical trial populations at our disposal, we study the cardiovascular benefits and risks of diabetes and antiplatelet therapies and other novel therapies, including influenza vaccination.

Women’s College Hospital is the first and only independent, academic, ambulatory care hospital in Ontario with a primary focus on the health of women. If you’re ready to be part of the future of healthcare, then you will want to join an institution in which the possibilities for creative innovation, breakthroughs in new thinking and groundbreaking work in academic ambulatory medicine are limitless. Women’s College Hospital is committed to patient safety as a key professional value and an essential component of daily practice.

The primary role of the Research Manager (RM) will be to manage and coordinate an international, multi-site clinical trial, working closely with the sponsor, vendors, and academic partners. The RM will be responsible for meeting study milestones on time and within budget. Duties will involve overseeing and implementing study protocols and research ethics board review, site management and training, monitoring for quality and regulatory compliance, informing development of the eCRF, coordinating group meetings, and overseeing internal and external study audits.

Additional Duties :
Monitoring the progress of research activities; develops and maintains records of research activities; prepares periodic and ad hoc reports, as required by investigators and funding agencies
Identifies threats and risk factors to project completion and works with team members including research assistants, coordinators and scientists to develop solutions
Works with relevant WCH departments to develop and establish research contracts and agreements with various external agencies and institutions
Prepares itemized budgets with appropriate justification for grant applications, ensuring that the research project represents a sustainable endeavor and that team resources are leveraged appropriately
Maintains financial records for projects, monitors spending against budget, completes projections, and works to ensure the financial sustainability of PI’s research portfolio overall
Clinical activities will include medical history taking, physical and medication assessments, phlebotomy, as appropriate
Supports the generation, ethics approval, conduct, and analysis of various data collection tools (patient surveys, data collection forms, interview guides, etc.) for projects
Responsible for oversight of all project research databases and records
Plans and coordinates the personnel of research studies including the recruitment and administration of research support staff
Manages team research coordinators, research assistants, and research students/trainees

As a role model and champion you will work to identify and integrate safe, best practices into daily activities to foster the delivery of safe and exemplary care.

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

Qualifications/Skills :
Master’s Degree Health Administration, Business Administration, Public Health, Health Science, Social Sciences, Health & Research Communications, and/or other recognized equivalent
CCRP designation in clinical research or a PMP designation in project management, preferred
Current registration in good standing with a regulated professional college preferred (i.e. College of Nurse of Ontario)
Five or more years of progressively responsible and related experience in planning and management processes in research and/or academic hospital
Familiarity with ICH/GCP guidelines and the Canadian and US regulatory environments required
Senior level experience working with clinical trials, including previous experience in a supervisory role
Experience with industry-sponsored research preferred
Previous research experience specializing in cardiology preferred
Outstanding written and verbal communication skills
Experience with preparation of relevant materials, such as manuscripts, grant submissions, study proposals, and research ethics board applications
Experience with budget planning/monitoring/managing and financial reporting
Experience prioritizing and working in a dynamic environment with strong management skills
Experience working independently with a high degree of initiative, discretion and tact
Experience working effectively with a wide variety of people at different levels
Demonstrated record of good performance and acceptable attendance will be considered as part of the selection criteria Professional behaviour and communication that meets the standards of the professional regulatory college or association, as applicable, and the standards of Women’s College Hospital This position plays a critical role in acting as an advocate for safety and will demonstrate principles, practices and processes that will optimize a safe environment for all

Women’s College Hospital is a fully affiliated teaching hospital of the University of Toronto and is committed to fairness and equity in employment and our recruitment and selection practices. We encourage applications from Indigenous peoples, people with disabilities, members of sexual minority groups, members of racialized groups, women and any others who may contribute to the further diversification of our Hospital community. Accommodation will be provided in all parts of the hiring process as required under our Access for People with Disabilities policy. Applicants need to make their requirements known in advance.