26 Sep
|
University Health Network
|
Mississauga
26 Sep
University Health Network
Mississauga
Traferox creates, manufactures and commercializes products for organ transplantation (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by transplant surgeons at partnering institutions, translating impactful clinical innovations into current standards of care. Traferox currently markets the TorEx Lung Perfusion System and the XPort Lung Preservation System and is committed to improving transplant outcomes and saving patients' lives.Location:The work will be performed in the company's place of work at 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5. This role may require some travel to clinical sites (< 10%).Traferox Technologies Inc.Union: Non-UnionNumber of Vacancies:1New or Replacement Position: NewSite:2400 Skymark Avenue,MississaugaDepartment: ClinicalReports to: Clinical Operations ManagerSalary Range:$75,000 - $95,000 annuallyHours:37.5 Hours Per WeekShifts: Days,Monday - FridayStatus: Permanent Full-timeClosing Date: August 19, 2026Position Summary:The Clinical Research Associate will support the end-to-end execution of clinical trials and post-market activities, ensuring studies are delivered in compliance with regulatory and company standards. The position supports trial start-up, conduct, and close-out. Through proactive communication, careful planning, effective management of timelines, and documentation, the successful candidate will help drive study progress and contribute to the delivery of high-quality clinical data. The role also involves collaborating with cross-functional teams to support the development and implementation of clinical research plans. This is a full-time, in-person role based in Mississauga, ON, with travel to partnering clinical sites as needed.Duties and Responsibilities:Support on-site trial start-up, conduct and close-out activities in accordance with industry and company standardsSupport clinical site interactions including assistance with REB/IRB applications,
enrollment tracking, CRF completion and issue resolutionTrack enrollment, study milestones, and timelines, maintaining up-to-date status trackers and dashboardsPrepare and maintain key clinical documents including protocols, informed consent forms, site agreements, amendments, CRFs, monitoring plans, project plans, data plans, summary and annual reportsMaintain Trial Master Files in compliance with ICH-GCP, Tri-Council Guidelines, PHIPA, HIPAA, Health Canada/FDA regulationsSupport data entry and query resolution in the EDC/eCRF system.Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, and confirm data completeness and accuracyContribute to regulatory submissions to Health Canada, FDA and under EU MDRCollaborate with project specific committees such as DSMBsDevelop tools to ensure accurate data collection and data integrityTravel as needed for site initiation and monitoring visitsUndergraduate degree in life sciences, health sciences, biomedical engineering, nursing, or a related field; a post-graduate degree in clinical research or a related field is an assetMinimum of 1 year ofclinical research experienceExposure to clinical trial design and data analysisStrong analytical and problem-solving skillsExperience working with cross-functional teams and effective collaboration skillsExcellent oral and written communication skillsStrong organizational skills and high attention to detail with the ability to manage multiple deadlines at onceAdditional Qualifications:Training in GCP/ICH guidelinesExperience in biostatistics, data science, and/or data quality managementExperience drafting, and maintaining a TMFExperience with site initiation visits, monitoring visitExperience in healthcare, medical devices or biotechnology industryWe thank all applicants for their interest in this position with Traferox Technologies Inc. Please note that only candidates selected for an interview will be contacted.
📌 Clinical Research Associate (Mississauga)
🏢 University Health Network
📍 Mississauga