OVERVIEW

We are seeking a dynamic Clinical Research Lead to join our Infectious Diseases (ID) team. This role will support ground breaking research being done locally, nationally and internationally, aimed at enhancing care and outcomes for patients with infectious diseases. At Michael Garron Hospital our Infectious Diseases research team is involved in clinical treatment trials for bacterial infections and observational studies aimed at viral transmission with an emphasis on emerging pathogens.
The successful candidate will be a superb communicator with an ability to explain complex medical concepts to patients and their families. Experience in clinical care is ideal to explain research studies for prospective study participants. Attention to detail is necessary to be able to manage multiple projects, follow protocols, and effectively coordinate between various partners while maintaining high ethical and regulatory standards. Experience with data management and electronic databases such as REDCap would be helpful, but above all, this position primarily entails coordination of randomized trials as the sponsor along with recruiting potentially eligible participants for research that will advance the treatment of infectious diseases. Although presence in the hospital is required weekdays, the position allows for remote work as part of the regular work week.
This role offers a unique opportunity to contribute to groundbreaking research in infectious diseases with publications in high impact medical journals.
This is a 1-year contract position, with the potential to renew.

EDUCATION

• Bachelor’s degree in a health or science-related field
• Certification as a Clinical Research Professional is an asset
• Graduate degree in health services research, epidemiology, public health or related field is preferred- Bachelor’s degree in a health or science-related field.

EXPERIENCE

• Minimum 5 years’ experience in clinical research required.
• Experience with patient-facing interactions required
• Knowledge of research regulations and guidelines including TCPS 2, ICH/GCP, Declaration of Helsinki, Health Canada Division 5, FDACode of Federal Regulations, required.
• Knowledge and experience in obtaining informed consent for research studies.
• Knowledge and experience in administering survey instruments.
• Computer skills, including word processing, spreadsheet, presentation and cloud computing (e.g. Zoom, Microsoft Teams, Microsoft365) and familiarity with Electronic Medical Records (EMR).
• Experience with computer data management and analysis software including REDCap™, SPSS™, preferred
• Excellent problem solving, critical thinking and time management skills
• Excellent written and oral communication skills
• Demonstrated skill in performing academic literature searches, completing grant applications,
• Professional and academic writing, preferred.
• Exceptional organizational skills and attention to detail.
• 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.

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