Site Specialist II

IRE-posted 3 days ago
Full-time • Mid Level
Remote • Hickory, NC
5,001-10,000 employees
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Site Specialist II - Remote - US ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development ICON is hiring for Site Specialist II and Sr. Site Specialist Title: Site Specialist II Role Summary: Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

  • Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
  • Support Site Partners on complex or on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
  • Support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
  • Ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
  • Support coordination of all necessary translations required for any start-up documentation.
  • Proficient in timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.
  • Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.
  • Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams to contribute and support risk identification to site activation, mitigation and action planning.
  • Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
  • Bachelor’s Degree
  • 3-6 years of experience in a Clinical Research environment
  • Demonstrate good organizational skills, ability to prioritize tasks and to deal with competing priorities
  • Good computer and Microsoft office knowledge
  • Completes tasks independently on time and in an efficient manner.
  • Ability to support other Site Specialists as needed.
  • Demonstrate ability to deal with internal stakeholders.
  • Demonstrate ability to identify study and site risks and properly document in tracking and reporting tools; support action planning with other study team stakeholders.
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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