Duties:

• Coordinate several clinical studies, including recruitment, obtaining informed consent, execution of all aspects of study visits and assessments, data management, monitoring of safety, maintenance of research assets. 
• Executing requirements at local site level and start-up activities for clinical trials
• Recruitment of study participants (e.g., identifying, screening potential participants and obtaining informed consent);
• Executing/coordinating all aspects of study visits as per study protocol (e.g. source documentation including adverse events, administration of questionnaires, etc.)
• Collect, enter, and maintain accurate study data in electronic databases (e.g., REDCap, Case Report Forms)
• Implement and coordinate all aspects of data management including data collection, data entry into CRFs, and source documentation, as per UHN policy and ICHI/GCP guidelines
• Ensure compliance with study protocols, institutional policies, and regulatory requirements (e.g., REB submissions, amendments, and documentation)
• Prepare and manage Research Ethics Boards (REB) submissions, amendments, renewals, and study documentation
• Maintain regulatory binders, regulatory files, and essential documentation in compliance with audit standards
• Liaise with Principal Investigators, study participants, sponsors, and interdisciplinary teams to support study execution
• Assist with study monitoring visits, audits, and resolution of data queries
• Support data cleaning, literature review
• Assist with dissemination of research results 
• Contribute to formatting, editing, and reference management 
• Support study close-out activities, including data verification and archiving