Clinical Research Operations Specialist

2 weeks ago


Kirkland, Quebec, Canada ICON Strategic Solutions Full time

Overview

At ICON Strategic Solutions, you will be joining the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence.

About the Role

We are seeking a highly skilled Clinical Trial Coordinator to join our team. As a key member of our operations team, you will play a critical role in ensuring the smooth execution of clinical trials.

Responsibilities:

  • Trial and Site Administration:
    • Update clinical trial databases (CTMS) and trackers;
    • Collate, distribute/ship, and archive clinical documents, e.g. eTMF;
    • Assist with eTMF reconciliation;
    • Execute eTMF Quality Control Plan;
  • Regulatory & Site Start-Up:
    • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions;
    • Support preparation of submission package for IRB/ERC and support regulatory;
    • Publish study results for GCTO and RA where required per local legislation;
  • Quality & Oversight:
    • 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).

Requirements:

  • Minimum 1-2 years in Clinical Research or relevant healthcare experience;
  • Completed job training (office management, administration, finance, health care preferred) or B.A./Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
  • 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;
  • Excellent negotiation skills for CTCs in finance area;
  • Effective communication with external customers (e.g. sites and investigators);
  • 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.

Compensation: $60,000 - $80,000 per annum, depending on experience.

Contact Information:



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