Clinical Trial Coordinator - Finance - Montreal, Canada

ICON Strategic Solutions; Canada; On-site; CAD 65,000 - 95,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Flexible benefits

Job summary

ICON plc in Canada seeks a detail-oriented Clinical Operations Associate to support budgeting, document management, site administration, and cross-country coordination. You will help prepare budgets, contracts, and study submissions while ensuring compliant processes across CTMS/eTMF systems.

You will manage on-site sponsor presence two days a week in Kirkland, collaborate with investigators and vendors, and maintain high standards of GCP compliance and data integrity.

Qualifications

• B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
• Minimum 1-2 years in Clinical Research or relevant healthcare experience.
• Must have at least 2 years of budget negotiation experience.
• Fluent in English and bilingual in French.
• Strong MS Excel skills and IT proficiency with MS Office.
• Good understanding of Global; Country/Regional Clinical Research Guidelines.
• Excellent time management and organizational skills.
• Ability to work independently in a multicultural environment.

Responsibilities

• Track and report essential documents and safety reports.
• Ensure collation and distribution of study tools and documents.
• Update CTMS and trackers.
• Clinical and non-clinical supply management in collaboration with country roles.
• Coordinate labeling changes and translation requests.
• Provide site evaluation/start-up materials and submissions.
• Obtain, track and update study insurance certificates.
• Support IRB/ERC submissions and regulatory agency submissions.
• Publish study results where required.
• Prepare Investigator trial file binders and documents.
• Execute eTMF Quality Control Plan and reconciliation.
• Obtain translations of documents.
• Develop country/site budgets and negotiate contracts (CTRAs).
• Maintain tracking tools and templates; ensure financial procedure compliance.
• Handle payments to investigators/vendors and budget closeout.
• Organize local investigator meetings and support logistics.

Skills

Budget negotiation

Clinical Research experience

French bilingual

MS Excel

Documentation management

Regulatory submissions

Communication skills

Time management

Education

Bachelor's degree in Life Science

Tools

CTMS

eTMF

MS Office

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Be Doing

• Tracking (e.g. essential documents) and reporting [e.g, Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in Collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request

Trial and site administration

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Document Management

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Execute eTMF Quality Control Plan
• Obtain translations of documents

Budgeting, Agreement and Payments

• Develop country and site budgets (including Split site budget)
• Tracking, and reporting of negotiations
• Maintenance of tracking tools
• Contract development, negotiation, approval and maintenance (e.g. CTRAs)
• Update and maintain contract; templates (in cooperation with Legal Department)
• Payment calculation and execution (investigators, vendors, grants)
• Ensure compliance with financial procedures
• Monitor and track adherence and disclosures
• Budget closeout.

Meeting Planning

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

What You Need To Have

• B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Minimum 1-2 years in Clinical Research or relevant healthcare experience
• Must have at least 2 years of budget negotiation experience.
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Must be bilingual in French
• Good understanding of Global; Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications; Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Able to work independently
• Proactive attitude to solving problems/ proposing solution
• Must be able to go on site to sponsor office 2 days a week in Kirkland
• Eligible to work in Canada without visa sponsorship

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.