Job Description Summary: Hours: 35 hours/week; 8:00 am -4:00 pm Monday-Friday Status: Full Time Level: 2 Years Experience Education & Qualifications: · At minimum, completion of a Bachelor of Science degree or recognized equivalent · Fluency in French is an asset. Duties & Responsibilities: The Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist) supports the development, coordination, and oversight of CMRG-sponsored clinical research from protocol development through activation, follow-up, and close-out. Key responsibilities include but are not limited to: Contribute to protocol development, drafting, and amendments Coordinate study activities across single- and multicentre trials to support timelines and deliverables Support regulatory compliance, including Health Canada submissions (e.g., CTA/NOL), amendments, reporting, documentation and trial master file management. Ensure trials are conducted in accordance with ICH-GCP, Health Canada, FDA, US Federal Code, and applicable institutional policies Support study management activities, including tracking milestones and deliverables Assist with clinical trial monitoring according to established plans and SOPs Participate in clinical database and eCRF development, testing, maintenance, and lock Perform data review, data cleaning, and query management to ensure accuracy and completeness Maintain trial master files, regulatory documentation, and data management files Communicate effectively with sites, investigators, sponsors, and internal teams Apply quality assurance procedures to support high-quality data collection and regulatory compliance Any other clinical research task assigned by the supervisor. Skills & Competencies: Experience managing and monitoring oncology trials Experience in regulatory management and Health Canada submissions Experience in database development using Medidata Rave and REDCap Demonstrated proficiency in English and French, with excellent oral and written communication skills Excellent organizational and prioritization skills, ability to learn quickly and independently Ability to work under pressure and attention to detail Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with CMRG standards Exercise initiative and good judgment with ability to multi-task Ability to work in a rapidly growing environment and able to quickly adapt to changes Knowledge of applicable legislative and regulatory policies. Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint). Professional Afflictions/Memberships SoCRA or ACRP designation preferred. Ability to travel up to 70% required. Industry Research Services Employment Type One Year Contract With possibility of Full Time position