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Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)
Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)Canadian Myeloma Research Group • Vaughan, ON, Canada
Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)

Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)

Canadian Myeloma Research Group • Vaughan, ON, Canada
Il y a 19 jours
Type de contrat
  • Temps plein
Description de poste

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

  • Research Services

    • Employment Type

    Full-time

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