Bilingual Clinical Research Monitor

Job descriptionThe bilingual clinical research monitor is responsible for monitoring clinical studies and is a key contact for investigational sites from the pre-study visit until study closure. The monitor will work remotely and travel to various sites for on-site monitoring visits. The monitor is responsible for training site personnel on protocols, CRFs, Good Clinical Practice and performs source data verification while ensuring compliance with GCP guidelines, SOPs and the protocol. Other responsibilities include: Ensuring that studies are being conducted in accordance with study protocol, GCP and SOPsPerforming source document verification of CRFsConducting drug accountability/reconciliationCollection/Review of CRFs and regulatory documentsIdentifying/Resolving problems at the study site to ensure subject safety and data qualityConducting pre-investigation visits, initiation, monitoring and close-out visitsQUALIFICATIONS Education:At a minimum, a completion of a Bachelor's degree program in a science or health related field, or recognized equivalent required.Post Graduate diploma in Clinical Research preferred.Experience:Two years practical and related experience preferred2 years of experience in clinical research and/or oncology preferredPrevious on-site monitoring experience an asset. Professional Affiliations/MembershipsSoCRA, ACRP designation preferred.CCPE accreditation is an asset Additional Skills & Functional/Technical Competencies: Bilingual proficiency in English and FrenchExcellent written and verbal communication skills required in order to deal with staff from various centres Excellent organizational and prioritization skills, good computer skills, ability to learn quickly and independently Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis standards. Exercise initiative and good judgment with ability to multi-task. Ability to work under pressure and close attention to detail Effective organizational, interpersonal and communication skills Knowledge of applicable legislative, regulatory and Ozmosis policies Proficiency in using clinical trial management systems Research Services