Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a Clinical Trial Coordinator - Regulatory/Finance in Montreal, Canada, you will be responsible for trial and site administration, document management, regulatory and site start-up responsibilities, budgeting, agreement and payments, and meeting planning.
Trial and site administration:
- Track and report on essential documents and safety reports
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases and trackers
- Manage clinical supply and non-clinical supply management in collaboration with other country roles
- Coordinate labeling requirements and translation change requests
Document management:
- Prepare documents and correspondence
- Collate, distribute, and archive clinical documents
- Assist with eTMF reconciliation
- Update manuals and documents
- Document proper destruction of clinical supplies
- Prepare investigator trial file binders
- Execute eTMF quality control plan
- Obtain translations of documents
Regulatory & Site Start-Up responsibilities:
- Provide and collect forms and lists for site evaluation, validation, and start-up
- Obtain, track, and update study insurance certificates
- Support preparation of submission packages for IRB/ERC and regulatory agencies
- Publish study results where required by local legislation
Budgeting, Agreement and Payments:
- Develop country and site budgets
- Track and report on negotiations
- Maintain tracking tools
- Contract development, negotiation, approval, and maintenance
- Update and maintain contract templates
- Payment calculation and execution
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures
- Budget closeout
Meeting Planning:
- Organize meetings and create study memos, letters, and protocols
- Support local investigator meetings
Requirements:
- B.A./B.S. in Life Science or equivalent healthcare experience
- Minimum 1-2 years in clinical research or relevant healthcare experience
- At least 2 years of budget negotiation experience
- Fluent in local languages and business proficient in English
- Bilingual in French
- Good understanding of global and country clinical research guidelines
- Hands-on knowledge of good documentation practices
- Good IT skills, including MS Office and clinical IT applications
- ICH-GCP knowledge
- Effective time management, organizational, and interpersonal skills
- High sense of accountability and urgency
- Ability to work independently and in a matrix multicultural environment
- Proactive attitude to solving problems and proposing solutions
- Eligible to work in Canada without visa sponsorship
Rewards & Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programs, including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Learning and development opportunities