Job description
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
Employment Type
Full-time
