Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)

Job description Job Description Summary:Hours: 35 hours/week; 8:00 am -4:00 pm Monday-FridayStatus: Full TimeLevel: 2 Years ExperienceEducation & 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 amendmentsCoordinate study activities across single- and multicentre trials to support timelines and deliverablesSupport 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 policiesSupport study management activities, including tracking milestones and deliverablesAssist with clinical trial monitoring according to established plans and SOPsParticipate in clinical database and eCRF development, testing, maintenance, and lockPerform data review, data cleaning, and query management to ensure accuracy and completenessMaintain trial master files, regulatory documentation, and data management filesCommunicate effectively with sites, investigators, sponsors, and internal teamsApply quality assurance procedures to support high-quality data collection and regulatory complianceAny other clinical research task assigned by the supervisor.Skills & Competencies:Experience managing and monitoring oncology trialsExperience in regulatory management and Health Canada submissionsExperience in database development using  Medidata Rave and REDCapDemonstrated proficiency in English and French, with excellent oral and written communication skillsExcellent organizational and prioritization skills, ability to learn quickly and independentlyAbility to work under pressure and attention to detailAbility to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with CMRG standardsExercise initiative and good judgment with ability to multi-taskAbility to work in a rapidly growing environment and able to quickly adapt to changesKnowledge of applicable legislative and regulatory policies.Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint).Professional Afflictions/MembershipsSoCRA or ACRP designation preferred. Ability to travel up to 70% required.Industry Research ServicesEmployment Type Full-time