Clinical Research Associate

Union: Non-Union
Number of Vacancies: 1
New or Replacement Position: New
Site:  2400 Skymark Avenue Mississauga 
Department: Clinical
Reports to: Clinical Operations Manager
Salary Range: $75000 - $95000 annually
Hours: 37.5 Hours Per Week
Shifts: Days Monday - Friday
Status: Permanent Full-time
Closing Date: August 19 2026

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.

Remote Work :

No

Employment Type :

Full-time