Clinical Trial Coordinator - Regulatory - Montreal

As a Clinical Trial Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Clinical Trial Coordinator (CTC)
Trial and site administration:

• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Track (e.g. essential documents) and report (e.g. Safety Reports)
• Manage Labeling requirements and coordinate/sign translation change request

Document management:

• Execute eTMF Quality Control Plan
• Document proper destruction of clinical supplies.
• Prepare documents and correspondence
• Prepare Investigator trial file binders
• Update manuals/documents (e.g., patient diaries, instructions)
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Obtain translations of documents
• Assist with eTMF reconciliation

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
• Budgeting, Agreement and Payments:
• Agencies submissions.
• Obtain, track and update study insurance certificates
• Publish study results for GCTO and RA where required per local legislation
• Support preparation of submission package for IRB/ERC and support regulatory

Collaborate with finance/budgeting representatives for:

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

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:
Clinical Trial Coordinator (CTC)

• ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
• Minimum 1-2 yrs in Clinical Research or relevant healthcare experience
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Proactive attitude to solving problems / proposing solutions
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Effective communication with external customers (e.g. sites and investigators)
• Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Highly effective time management, organizational and interpersonal skills, conflict management
• Demonstrates commitment to Customer focus, both internally and externally.
• Excellent negotiation skills for CTCs in finance area
• 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.
• Able to work independently taking full ownership of delegated tasks
• Hands on knowledge of Good Documentation Practices
• To qualify, applicants must be legally authorized to work in Camada, and should not require, now or in the future, sponsorship for employment visa status
• ICH-GCP Knowledge appropriate to role

Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.