Study Start Up Associate I

hace 4 semanas


Xico, México Icon A tiempo completo

The Study Start Up Associate I at Icon is responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines, and the principles of ICH/GCP.

Key responsibilities include:

  • Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
  • Negotiating Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF
  • Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries to Country and Site Specific ICFs
  • Negotiating and executing Clinical Trial Agreements (CTA)
  • Establishing and maintaining effective and proactive communication with Study Sites, Sponsors, and internal personnel regarding the status of budgets, contracts, and any other contract-related documents

As a Study Start Up Associate I, you will work closely with key stakeholders to optimize performance and collaborate to ensure successful project outcomes. You will also assume responsibility as a Subject Matter Expert (SME) as required.

Icon is committed to delivering high-quality services to our clients, and we are seeking a highly skilled and detail-oriented individual to join our team as a Study Start Up Associate I.



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