Clinical Research Manager, Infectious Diseases

OVERVIEW Join Michael Garron Hospital (MGH), a vibrant urban teaching hospital in East Toronto, as our next Clinical Research Manager in Infectious Disease. At MGH, we believe learning and discovery are the cornerstones of advancing healthcare, driving us to innovate, adapt, and challenge the status quo.  The Clinical Research Manager will provide administrative support, project management and oversight for PRECISE (Prepare, REact, Collect, Innovate, Share and Engage). This exciting multi-component pandemic preparedness project supported by the Canada Biomedical Research Fund seeks to develop an agile, equitable research and bio-manufacturing response to emerging infectious disease threats. The Clinical Platform of PRECISE features a master protocol for longitudinal prospective cohort studies, with comprehensive data and biological specimen collection from individuals with emerging infections, and their close contacts. The study is in the process of obtaining regulatory approvals, after which it will be implemented across an initial network of 21 adult and pediatric infectious diseases research sites across community and academic hospitals in Ontario with a goal of expanding to additional sites. To help launch this important work, we are seeking a highly organized team player to serve as a Clinical Research Manager for the PRECISE Clinical Platform. Key responsibilities for this role will include: extending the existing Master Protocol and related study documents to include inter-pandemic infections and related research projects, maintaining Research Ethics Board approvals at multiple institutions, developing study procedures suitable for this large multi-institutional collaboration, supporting a team of research coordinators across different organizations, ensuring meaningful community engagement, and overseeing the day-to-day operations of this multi-faceted project. The Manger will share duties with a co-Lead, with each overseeing individual projects within PRECISE, and collaborating to build and maintain stakeholder relationships across the network. The Manager will work closely with the four co-Principal Investigators, as well as the staff and leadership of other components of PRECISE. The ideal candidate will have exceptional organizational, interpersonal and leadership skills. PRIMARY RESPONSIBILITIES Project Management - Oversight of a randomized controlled trial as the sponsor - Assist with Research Ethics Board submissions, contracts, training and consent form construction - Manage REDCap and similar electronic databases - Ensure regulatory compliance of randomized controlled trials - Coordinate meetings with steering committees, data monitoring and safety committees and statistical working groups - Incorporate feedback into trial documents Study Management: - Screen and recruit potentially eligible study participants, obtain informed consent, and initiate and maintain study files and research charts. - Liaise with the treating healthcare team to identify eligible subjects for recruitment and ensure fidelity to research protocols - Ensure adherence to study protocols and regulatory requirements including Research Ethics Board applications and Data Sharing Agreements - Input data into electronic databases - Monitor study timelines, maintain budgets and ensure compliance with financial reporting - Work with infectious disease physicians/investigators to establish research priorities, data elements and engagement/sustainability strategies - Assist in training/orientation of new research staff Data Analysis and Reporting: - Assist in database development, analysis of registry data and study results - Prepare presentations, progress reports, and scientific manuscripts Collaboration: - Encourage and foster collaborative relationships with healthcare teamsat Michael Garron Hospital and with study teams at other participating centres. Project Development: - Contribute to the design and implementation of new research initiatives - Assist in grant writing and funding applications EDUCATION - Bachelor’s degree in a health or science related field required - MSc or above in Infectious Disease, Microbiology, Immunology, Cell Biology or a related field or healthcare professional degree preferred EXPERIENCE - At least 5 years of experience in clinical research - At least 5 years of experience in research project management or equivalent leadership role - Experience in infectious/communicable disease research preferred - Current certification in Good Clinical Practice, Ethical Conduct for Research Involving Humans, and Transportation of Dangerous goodsSuperior interpersonal skills and attention to detail - Excellent problem-solving and organizational skills and ability to respond rapidly to change - Experience with clinical databases such as REDCap or InForm  - Ability to work well as part of a multidisciplinary team - Excellent written and oral communication skills - Able to work independently, without immediate supervision, and as part of a team - A high degree of professionalism and respect for colleagues. - Demonstrated ability to manage conflicting priorities and confidential data. - Good work and attendance record required. - All employees of Michael Garron Hospital (MGH), a division of Toronto East Health Network (TEHN) [formerly Toronto East General Hospital (TEGH)] agree to work within the legislated practices of the Occupational Health and Safety Act of Ontario. - All employees of MGH are responsible for contributing to a transparent culture of patient and staff safety by adhering to and abiding by patient and staff safety policies and procedures set by MGH. - All employees are accountable for protecting the psychological health and safety of themselves and their co-workers through adherence to MGH's policies and practices.. 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