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Clinical Trial Specialist

2 months ago

Vaughan ON, Canada Canadian Myeloma Research Group Full time

Hours: 35 hours/week; 8:00 am -4:00 pm Monday-FridayStatus: Permanent Full TimeLevel: 2 Years ExperienceEducation & 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 managementClinical trial monitoring according to developed plans and SOPsClinical database developmentCoordinating single and/or multicentre studiesProtocol development, writing, and amendmentsRegulatory complianceCommunication with various sites, staff and sponsors at all levelsUtilize quality assurance procedures to ensure that high quality data is obtainedEnsuring studies are conducted in accordance with ICH-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agenciesSkills & Competencies:Experience managing and monitoring oncology trialsExperience in database development and Medidata Rave an assetDemonstrated proficiency in English and French, with excellent oral and written communication skillsExcellent organizational and prioritization skills, ability to learn quickly and independentlyAbility to work under pressure and attention to detailAbility to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with CMRG standardsExercise initiative and good judgment with ability to multi-taskAbility to work in a rapidly growing environment and able to quickly adapt to changesKnowledge of applicable legislative and regulatory policies.Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint).Professional Afflictions/MembershipsSoCRA or ACRP designation preferred.Ability to travel up to 70% required.