Job description

The 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 SOPs
• Performing source document verification of CRFs
• Conducting drug accountability/reconciliation
• Collection/Review of CRFs and regulatory documents
• Identifying/Resolving problems at the study site to ensure subject safety and data quality
• Conducting pre-investigation visits, initiation, monitoring and close-out visits

QUALIFICATIONS

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:

• 2 years practical and related experience preferred
• 2 years of experience in clinical research and/or oncology preferred
• Previous on-site monitoring experience an asset.

Professional Affiliations/Memberships

• SoCRA, ACRP designation preferred.
• CCPE accreditation is an asset

Additional Skills & Functional/Technical Competencies:

• Proficiency in English
• Excellent 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
• Proficiency in French would be an asset but not required