Clinical Trial Specialist
7 hours ago
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.
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