Study Start Up Associate II

hace 3 días


Ciudad de México, Ciudad de México Icon A tiempo completo
Job Summary

We are seeking a highly skilled Study Start Up Associate II to join our team at ICON. As a key member of our team, you will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation.

Key Responsibilities
  • Collect, prepare, review, approve, process, and track 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.
  • Embody and contribute to ICON's culture of quality and process improvement, focusing on enhancing processes, systems, and tools to add value to our business and meet or exceed client needs.
  • Recognize, exemplify, and adhere to ICON's values of Accountability and Delivery, Collaboration, Partnership, and Integrity, which center around our commitment to Ownership.
  • Travel (approximately 5%) domestically and/or internationally, attending kick-off, investigator, or study team meetings as required.
  • Perform timely and accurate task progress communication and data entry of all relevant study start-up activities into the appropriate tracking system.
  • Serve as the main point of contact with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads, and third parties, working with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
  • Assume responsibility as Subject Matter Expert (SME) as required.
  • Coordinate all necessary translations required for any start-up documentation.
  • Attend study team meetings as required.
  • Other duties as assigned.
Requirements
  • Proficient knowledge of ICON SOPs/WPs, ICH/GCP, and applicable country regulations/guidelines and ICON systems.
  • Ability to perform timely and accurate task progress communication and data entry of all relevant study start-up activities into the appropriate tracking system.
  • Excellent communication and collaboration skills, with the ability to work effectively with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads, and third parties.
  • Ability to assume responsibility as Subject Matter Expert (SME) as required.
  • Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.


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