Clinical Research Associate (Data & Regulatory Compliance) …, London

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 qualified 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 Power Point). 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 Apply on Kit Job: kitjob.ca/job/2p9ve8