Clinical Research Manager

6 months ago

Toronto, Canada Sinai Health Full time

In 2015, Bridgepoint Active Healthcare, Circle of Care, Lunenfeld-Tanenbaum Research Institute and Mount Sinai Hospital, came together to form Sinai Health System - and leverage our collective expertise and create a system that better responds to the changing needs of our patients, families and clients. Sinai Health has a bold vision and strategy for the future: To create Canada's leading health system pushing the boundaries to realize the best health and care for complex patients.

A key enabler of this vision is Sinai Health’s People Plan - which provides an explicit commitment to our people about our commitment to creating a workplace culture and environment that is safe, caring, equitable, compassionate and accountable in order to ultimately provide optimal care to patients and their family caregivers.

To support us on our journey, Sinai Health System is looking for a **Clinical** **Research Manager** to support our **Obstetrics and Gynaecology Department** at our **Mount Sinai Hospital Campus**.

The Clinical Research Manager for the Department of Obstetrics and Gynaecology works closely with the Head of Clinical Research to manage the overall research team and program. He/she is responsible for project management, resourcing, account management, team development and knowledge translation/dissemination. The Research Manager helps set goals, oversees research projects and is responsible for the operational and financial aspects of the projects under his/her portfolio. This includes coordinating Research Ethics Board submissions, developing and communicating project plans, status reports, budgets and other reports, as well as long-term planning of on-going projects, day-to-day operations of on-going studies, and development of new projects. He/she may also assume Clinical Research Coordinator responsibilities as required. This person is highly motivated with the ability to influence and inspire others. This job typically requires a graduate degree and previous management and research experience.

**Responsibilities**
- Responsible for management of all research staff (research coordinators, research assistants, trainees, and volunteers) including job descriptions, recruitment, selection, payroll, succession planning, training needs, and ongoing oversight;
- Collaborates with Human Resources for new hires, promotions, contracts, and dismissals;
- Keeps abreast of regulations and policies governing clinical research and communicate to staff and research team members. (e.g., Tri-council Policy Statement, Good Clinical Practice, and Health Canada and FDA regulations). Develops policies and procedures related to the research program, ensuring external regulations and guidelines are followed;
- Collaborates with research team (i.e. principal investigators, research coordinators, statisticians, etc) to discuss research design/areas for improvement/strategies for execution and provides on-going oversight and support for active research projects including Health Canada-regulated clinical trials;
- Ensures that all assigned projects are sufficiently and appropriately resourced and that all regulatory and ethical guidelines are being adhered to;
- Develops study documents including protocols, questionnaires, case report forms, informed consent documents, etc. based on regulations, REB templates and institutional requirements;
- Assists in designing databases for participant follow-up and eCRF’s;
- Directs the development/maintenance of quality control procedures for accurate and secure data collection and management;
- Assigns staff/teams to projects, taking into consideration:

- existing project teams and continuity
- skills required for the project
- current workloads and timelines
- team dynamics and interpersonal skills
- Collaborates with Grants Administration, Finance, and Technology Transfer office for budget and contract negotiation and management;
- Provides oversight to the department and research project budgets including grant reporting and finance reconciliation
- Prepares and submits research expense reimbursements through Research Accounting, ensuring all original supporting documentation is attached;
- Responsible for maintaining research staff budgets and cost recoveries from respective studies;
- Scrutinizes proposed timing and resources for projects and discusses them with the key sites, investigators and departments to ensure that project needs are met.
- Keeps abreast of outstanding proposals to foresee and plan workload levels and resource requirements;
- Other duties as assigned
- Job Requirements- MSc in a relevant health research discipline or an equivalent combination of education and experience
- Experience coordinating research projects, including human resources and financial management
- Experience handling multiple priorities and meeting competing deadlines
- Knowledge of external funding agencies’ policies and procedures
- Knowledge of regulatory and ethical requirements for

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