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Dernière mise à jour : il y a 2 jours
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Support the implementation of ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Clinical Trial Specialist
Canadian Myeloma Research GroupVaughan, ON, CanadaIl y a 3 jours
Type de contrat
- Temps plein
- CDI
Description de posteStudy 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 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). SoCRA or ACRP designation preferred.
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 :
Skills & Competencies :
Professional Afflictions / Memberships
Ability to travel up to 70% required.