Clinical Research Associate; Data & Regulatory Compliance

Position: Clinical Research Associate (Data & Regulatory Compliance )
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   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).
Qualified Afflictions/Memberships   SoCRA or ACRP designation preferred.
Travel Requirement  Ability to travel up to 70% required.
Industry  Research Services

Employment Type

One Year Contract With possibility of Full Time position

#J-18808-Ljbffr