Bilingual Clinical Trial Coordinator

2 weeks ago

Kirkland, Quebec, Canada ICON Strategic Solutions Full time

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:

  • 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)

Quality & Oversight: (for Senior CTC level)

  • Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Mentors / buddies junior CTCs (including, but not limited to process requirements)

What you need to have:

Clinical Trial Coordinator (CTC)

  • Minimum 1-2 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
  • 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
  • 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 Canada, and should not require, now or in the future, sponsorship for employment visa status

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