Bilingual Clinical Trial Coordinator - Regulatory- Montreal

ICON Strategic Solutions; Kirkland; Hybrid; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive base salary

Performance-related incentives

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Job summary

ICON Strategic Solutions is seeking a detail-oriented professional to support trial and site administration, document management, regulatory submissions, budgeting, and meeting planning in a sponsor-dedicated model.

The role involves on-site presence 2 days/week in Kirkland, bilingual French required, and strong MS Excel/IT skills to ensure compliance with GCP and global guidelines. Competitive rewards and growth opportunities offered.

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 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

Responsibilities

• Track and report essential documents and safety reports
• Update clinical trial databases (CTMS) and trackers
• Manage labeling requirements and translation change requests
• Prepare investigator trial file binders and document control
• Support regulatory submissions and site start-up activities
• Develop country/site budgets and track negotiations
• Support meeting planning and material preparation

Skills

MS Excel

ICH-GCP Knowledge

Communication

Time management

French bilingual

MS Office

Education

B.A./B.S. in Life Science

Tools

CTMS

eTMF

MS Office

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What you will be doing:

Trial and site administration:

• 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

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

Regulatory & Site Start-Up responsibilities:

• 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

Budgeting, Agreement and Payments:

• Collaborate with finance/budgeting representatives for
• 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:

• 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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.