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

Clinical Research Associate (Clinical Data & Regulatory Affairs Specialist)

Canadian Myeloma Research Group • Vaughan, ON, Canada

20 days ago

Job type

Full-time

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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Associate Associate • Vaughan, ON, Canada

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