Clinical Trial Coordinator - Regulatory/Finance

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Clinical Trial Coordinator in Montreal, Canada. The role covers regulatory and site start-up, document management, budgeting, agreement and payments, and meeting planning for clinical trials.

Key responsibilities

• Trial and site administration: track and report documents such as safety reports, collate and distribute study tools, update CTMS databases and trackers, manage clinical and non-clinical supply, and coordinate labeling and translation change requests
• Document management: prepare and archive clinical documents, assist with eTMF reconciliation, update manuals and patient diaries, destroy clinical supplies properly, prepare investigator trial files, obtain translations and run the eTMF quality control plan
• Regulatory and site start-up: provide and collect forms for site evaluation and validation, track study insurance certificates, support IRB/ERC and regulatory submissions, publish study results where required, and close out budgets
• Budgeting, agreements and payments: develop country and site budgets, track negotiations, negotiate and approve contracts (e.g. CTRAs), calculate and execute payments to investigators, vendors and grants, and monitor financial compliance
• Meeting planning: organize meetings, create and track study memos, letters and protocols, and support local investigator meetings

Required profile

• B.A./B.S. (life science preferred) or equivalent healthcare experience, with at least 1-2 years in clinical research or a related field
• At least 2 years of budget negotiation experience
• Fluent in French and business-proficient in English, with good communication skills
• Eligible to work in Canada without visa sponsorship; must be able to travel to the sponsor's office in Kirkland two days a week

Required skills

• Good documentation practices and ICH-GCP knowledge
• Strong MS Excel skills and basic clinical IT applications
• Understanding of global, country and regional clinical research guidelines

What we offer

• Competitive base salary and performance-related incentives
• Medical, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities