# Clinical Trial Coordinator - Regulatory/Finance

**Company**: ICON
**Location**: Montreal, QC
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Canada-Montreal/Clinical-Trial-Coordinator---Finance---Montreal--Canada_JR155656?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_83a4f9af-3f8

## 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

## Skills

### Required
- clinical research
- budgeting
- regulatory affairs
- document management
- meeting planning
- MS Office
- ICH-GCP
- French

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Canada-Montreal/Clinical-Trial-Coordinator---Finance---Montreal--Canada_JR155656?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)