About The Role

Clinical Trial Coordinator - Regulatory - Montreal
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.

Track (e.g. essential documents) and report (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

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

Collaborate with finance/budgeting representatives for:
Develop, control, update and close-out country and site budgets (including Split site budget)
Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures,
Maintain tracking tools

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

Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
Fluent in Local Languages (French) and business proficient in English (verbal and written) and excellent communication skills
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.
Effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.g. sites and investigators)
ICH-GCP Knowledge appropriate to role
Excellent negotiation skills for CTCs in finance area
Ability to be on site at client 2 days a week.
To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status

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.

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

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