Clinical Research Monitor, Canadian Regional Coordinating Centre

EASi-KIDNEY (A multicenter international randomized double-blind placebo-controlled clinical trial of the aldosterone synthase inhibitor in patients with chronic kidney disease treated with empagliflozin) is a large international investigator-initiated study, run through the University of Oxford and sponsored by Boehringer Ingelheim.  The Canadian Regional Coordinating Centre (RCC), led by Drs. Adeera Levin and David Cherney, provides oversight and support to approximately 24 trial sites across Canada. This position serves as a Clinical Research Monitor, responsible for monitoring oversight of Canadian sites. The incumbent performs national-level responsibilities, including frequent on-site monitoring across Canada to ensure compliance with ICH-GCP, Health Canada regulations, institutional SOPs, and protocol requirements.   This is a contracted role that is fully remote.  Preference is for the incumbent to reside in the Montreal/GTA Area.

Organizational Status

The Clinical Research Monitor will report directly to the National Coordinator. The RCC team reports to the Central Coordinating Office at the University of Oxford and liaise with the Canadian trial sites to facilitate trial conduct.

Work Performed

Monitoring and Oversight 

• Conducts all site monitoring visits (initiation, routine monitoring, and close-out).
• Ensures site compliance with ICH-GCP, SOPs, Health Canada Division 5 regulations, and protocol requirements.
• Verifies informed consent processes, regulatory binders, essential documents, and Investigator Site Files (ISFs).
• Oversees drug accountability (storage, dispensing, return, destruction) and pharmacy compliance.
• Monitors patient safety, ensuring timely and accurate AE/SAE reporting.
• Reviews data entry and source verification and escalates risks when needed.
• Tracks and verifies site staff training records and compliance documentation.
• Maintains accurate monitoring reports and logs
• Respond to technical, medical and administrative queries from sites.
• Prepares sites for audits/inspections by ensuring readiness of essential documents and source data
• Maintain the database (Cantata)  by verifying consistency across site logs, delegation records, and monitoring reports.
• Meet with the Principal Investigator to discuss recruitment or site challenges
• Provide feedback to assist sites which includes summary of overall site functioning and detected deficiencies and corrective action needed, follow up with sites until deficiencies are resolved.
• Responsible for scheduling and arranging all logistics for timely monitoring visits according to the monitoring SOP
• Train site personnel regarding the trial
• Available for a  point of contact for site support.
• Communicate and report to the National Coordinator regarding the monitoring visits
• Travels nationally across Canada (primarily Ontario, Quebec and Nova Scotia) to perform monitoring visits.

Preferred Qualifications

• Completion of a bachelor's degree plus a minimum of two years directly related experience in clinical trials research; and
• Independent on-site monitoring experience
• Full working proficiency in English (mandatory) and French is an asset
• Proficiency in MS Office applications (Word, Excel, Outlook) and other electronic communications
• Ability to travel within Canada
• Valid driver’s license
• Excellent troubleshooting and organizational skills to prioritize workload to meet deadlines as well as well as a strong attention to detail.
• Proven capability in identifying problems and developing creative solutions.
• Effective oral and written communication and demonstrates responsibility and accountability.
• Able to work independently with little supervision

Salary Range

• $45-55/hr rate including travel time + daily per diem
• Casual-part-time contract

Contact Amanda Axler, Amanda.axler@phc.ca, to apply for this position.