Study Support Assistant

2 days ago

Waterloo, Ontario, Canada ICON Strategic Solutions Full time
Job Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a skilled professional to support the team in various administrative and coordination tasks.

Responsibilities
  • Embody ICON's values centered around People, Clients, and Performance, and contribute to a culture of process improvement.
  • Provide general administrative support to the team, including tracking, filing, and coordinating tasks.
  • Support Study Start Up Leads in tasks such as tracking, filing, and coordinating submissions.
  • Collate and verify submission documentation for Regulatory/Competent Authority (CA)/Ethics Committee (EC) and other relevant authorities.
  • Coordinate and dispatch submissions to CNEC and other relevant authorities.
  • Assist in translating documents required for submission to CNEC and other relevant authorities.
  • Track submission progress by updating the relevant ICON/Sponsor tracking system.
  • Copy and route incoming correspondence, internal documentation, and other relevant materials.
  • Be familiar with ICH GCP and relevant ICON SOPs.
  • Be competent with ICON/sponsor Clinical Trial Management System (CTMS).
  • Set up, organize, and maintain department electronic filing systems.
  • Assist in coordinating payments to CA/EC and other relevant authorities.
  • Set up and organize meetings, as requested.
  • Attend team meetings and generate meeting minutes.
Requirements
  • University degree in Health Science or a related field.
  • Two years of experience in Clinical Research or a related industry.
  • Oncology experience required.
  • Understanding of Good Clinical Practices/International Committee on Harmonization principles.
  • Strong social and interpersonal skills (written and oral).
  • Ability to influence without authority.
  • Effective time management skills.
  • Good knowledge of MS Office (Word, Excel, PowerPoint).

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