Clinical Trial Coordinator

2 weeks ago

Montreal, Quebec, Canada ICON plc Full time
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:

Clinical Trial Coordinator (CTC)

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 & nonclinical 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 closeout 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)

What you need to have:

Clinical Trial Coordinator (CTC)

  • Minimum 12 yrs in Clinical Research or relevant healthcare experience
  • Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Hands on knowledge of Good Documentation Practices
  • ICH-GCP Knowledge appropriate to role
  • Excellent negotiation skills for CTCs in finance area
  • Highly 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, both internally and externally.
  • Able to work independently taking full ownership of delegated tasks
  • Proactive attitude to solving problems / proposing solutions
  • To qualify, applicants must be legally authorized to work in the Canada and should not require, now or in the future, sponsorship for employment visa status
-
ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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 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 maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's wellbeing
  • Life assurance
  • Flexible countryspecific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health as

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