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Clinical Trial Specialist

Clinical Trial Specialist

Canadian Myeloma Research GroupVaughan, ON, Canada
10 days ago
Job type
  • Full-time
  • Permanent
Job description

Job Description Summary :

Hours : 35 hours / week; 8 : 00 am -4 : 00 pm Monday-Friday

Status : Permanent 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 Trials Specialist  (CTS) participates in the development, coordination, data and project management of clinical trials from protocol development / review, approval through to activation, follow-up and trial closure. The CTS is responsible for a wide variety of projects involving phase, I and II clinical trials sponsored by CMRG. Principal responsibilities include :

  • Study management
  • Clinical trial monitoring according to developed plans and SOPs
  • Clinical database development
  • Coordinating single and / or multicentre studies
  • Protocol development, writing, and amendments
  • Regulatory compliance
  • Communication with various sites, staff and sponsors at all levels
  • Utilize quality assurance procedures to ensure that high quality data is obtained
  • Ensuring studies are conducted in accordance with ICH-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agencies
  • Skills & Competencies :

  • Experience managing and monitoring oncology trials
  • Experience in database development and Medidata Rave an asset
  • 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.