Job Description

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.

Responsibilities include, but are not limited to:

Trial and site administration:

• 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

Document management:

• Prepare documents and correspondence

• Collate, distribute/ship, and archive clinical documents, e.g. eTMF

• Assist with eTMF reconciliation

• Execute eTMF Quality Control Plan

• Update manuals/documents (e.g., patient diaries, instructions)

• Document proper destruction of clinical supplies.

• Prepare Investigator trial file binders

• Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• 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, 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

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Qualifications, Skills and Experience:

• Minimum 1-2yearsinClinicalResearchorrelevanthealthcare experience

• Completed job training (office management, administration, finance, health care preferred)orB.A./B.S.(LifeSciencepreferred)orequivalenthealthcareexperience.

• FluentinLocal Languages (French)andbusinessproficientinEnglish(verbalandwritten) and excellent communication skills

• GoodunderstandingofGlobal,Country/RegionalClinical ResearchGuidelinesandabilityto work within these guidelines.

• HandsonknowledgeofGoodDocumentation Practices

• GoodITskills(Useof MSoffice, useof someclinicalITapplicationsoncomputer)andability 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-GCPKnowledgeappropriateto role

• ExcellentnegotiationskillsforCTCsinfinance 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.

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