Clinical Trial Coordinator - Finance - Montreal, Canada

ICON plc • Montreal, QC

8d • Onsite

About The Position

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to جديد 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.

Requirements

• 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.

Responsibilities

• 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)

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level