Clinical Trial Coordinator - Regulatory/Finance - Montreal, Canada

Clinical Trial Coordinator - Regulatory/Finance - Montreal, Canada

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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:

• 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

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

Rewards & Benefits

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.

Visit our careers site to read more about the benefits ICON offers.

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.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply