.At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.**Title**: Study Start Up Associate I (SSU I)**Summary**:As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.- Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirement- Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager - Central Services or Designee.- Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):- Be involved as required in the preparation, review and/or approval of Country Master ICF templates.- Negotiate 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. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.- Review, negotiate and approve all Ethics Committee (EC) and Institutional Review Board (IRB) queries to Site Specific ICFs.- Prepare, review and approve amended Site Specific amended ICFs.- Negotiation and Execution of Clinical Trial Agreements (CTA):- Prepare, review and negotiate CTAs, budgets and any required ancillary agreements with assigned Study Sites.- Prepare and oversee all contractual documents and correspondence, including the facilitation of the indemnification process, between Sponsor and Study Site.- Establish and maintain effective and proactive communication with Study Sites and internal personnel regarding the status of budgets, contracts and any other contract-related documents
