Clinical Research Associate

Company Description

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 new standards of care. Traferox currently markets the TorEx Lung Perfusion System and the X°Port 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%).

Job Description

Union:  Non-Union

Position 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 standards
• Support clinical site interactions including assistance with REB/IRB applications, enrollment tracking, CRF completion and issue resolution
• Track enrollment, study milestones, and timelines, maintaining up-to-date status trackers and dashboards
• Prepare and maintain key clinical documents including protocols, informed consent forms, site agreements, amendments, CRFs, monitoring plans, project plans, data plans, summary and annual reports
• Maintain Trial Master Files in compliance with ICH-GCP, Tri-Council Guidelines, PHIPA, HIPAA, Health Canada/FDA regulations
• Support 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 accuracy
• Contribute to regulatory submissions to Health Canada, FDA and under EU MDR
• Collaborate with project specific committees such as DSMBs
• Develop tools to ensure accurate data collection and data integrity
• Travel as needed for site initiation and monitoring visits

Qualifications

• Undergraduate 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 asset
• Minimum of 1 year of clinical research experience
• Exposure to clinical trial design and data analysis
• Strong analytical and problem-solving skills
• Experience working with cross-functional teams and effective collaboration skills
• Excellent oral and written communication skills
• Strong organizational skills and high attention to detail with the ability to manage multiple deadlines at once

Additional Qualifications:

• Training in GCP/ICH guidelines
• Experience in biostatistics, data science, and/or data quality management
• Experience drafting, and maintaining a TMF
• Experience with site initiation visits, monitoring visit
• Experience in healthcare, medical devices or biotechnology industry

Additional Information

We 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.