Clinical Trial Coordinator - Regulatory - Montreal
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.

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 1-2yearsin

Clinical

Researchorrelevanthealthcareexperience
Completed job training (office management, administration, finance, health care preferred)orB.A./B.S.(Life

Sciencepreferred)orequivalenthealthcareexperience.

Fluentin

Local Languages (French)andbusinessproficientin

English(verbalandwritten) and excellent communication skills
Goodunderstandingof

Global,Country/Regional

Clinical Research

Guidelinesandabilityto work within these guidelines.

Handsonknowledgeof

Good

Documentation

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-GCPKnowledgeappropriatetorole
ExcellentnegotiationskillsforCTCsinfinancearea
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
**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 market-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, Life

Works, 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.

Visit our careers site (https://careers.iconplc.com/benefits)
to read more about the benefits ICON offers.

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 (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld)
to apply

📌 Clinical Trial Coordinator (Montreal)
🏢 ICON Clinical Research
📍 Montreal