Clinical Trial Coordinator - Finance - 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.

What You Will Be Doing

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

Trial and site administration

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

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

Budgeting, Agreement and Payments

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

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 competitive salary, ICON offers a range of additional benefits. Our benefits…