To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03190

About our client Our client is a publicly traded pharmaceutical company with over 10 years of success in the development and commercialization of therapeutics for critical unmet patient needs. The company has an experienced management team, strong revenue growth and a deep pipeline of highly innovative products. They have developed an industry-wide reputation for a positive environment that emphasizes empowerment, transparency and teamwork. This is a great opportunity for someone that wants to put their drive and initiative to work. Position Location Regional Monitor (Home-Based) Western Canada Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor clinical trial activities while ensuring compliance with FDA regulation, ICH/GCP guidelines and company SOPs 2) Support the Internal Operations Team 3) Liaise with assigned sites to ensure expected obligations are met (compliance with protocol, data quality, IRB reporting standards, etc.) 4) Collect regulatory documents and perform study drug management as well as reconciliation throughout the study 5) Conduct all aspects of site monitoring including pre-study, site initiation, interim monitoring and closeout visits 6) Liaise with the site and company to develop and maintain rapport with site study staff 7) Ensure site staff has adequate materials and training to conduct the study 8) Verify the ongoing suitability of investigators and sites throughout the conduct of a study 9) Document site contacts (thoroughly and concisely), performance and all visit- related activities as per SOP 10) Verify data integrity by source document review, CRF entry validation and data clarifications 11) Identify and resolve areas of deficiencies at participating sites 12) Hold discussions with appropriate site staff and investigators 13) Handle re-training of site staff and refer escalation of matters to CTM or ROM (as appropriate) 14) Perform query resolution in a timely manner 15) Verify Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported according to protocol guidelines 16) Ensure investigational product is accounted for and that substantiating documentation is maintained 17) Ensure proper maintenance of site’s regulatory binder and company Investigator files through regular review 18) Perform tasks as outlined in the protocol and monitoring guidelines 19) Submit accurate and timely monitoring visit reports, expense reports, time sheets and invoices 20) Ensure prudent use of company resources by completing tasks and travel in an economical method 21) Attend Monitor/Investigator meetings 22) Maintain appropriate databases to update site visit dates 23) Check digital pen and paper data (e.g. light logical checks) 24) Review query status Requirements 1) Bachelor’s Degree, preferably in Science or health-related discipline 2) Minimum 5 years of monitoring experience with direct site monitoring 3) Superb knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines (FDA, ICH/GCP, etc.) 4) Excellent communication skills (written and verbal) 5) Strong organizational, time management and problem-solving skills 6) Ability to work independently with minimal supervision 7) Ability to understand and manage multiple complex protocols and monitoring plans 8) Proficiency in computers and standard computer applications 9) Flexible individual with willingness to travel routinely (as the project dictates)