Site Specialist Ii

ICON plc

United States
Site support activities
Regulatory and site level critical documents
Study site activation
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

Job 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.
  • Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to ensure successful site activation and project outcomes.
  • In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Matching 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.

Skills & Requirements

Must-have

  • site support activities
  • regulatory and site level critical documents
  • study site activation
  • ICH/GCP
  • Critical Document Package (CDP)
  • Trial Master File (TMF)

Nice-to-have

  • culture of quality and process improvement
  • proactive, service-focused mindset
  • inclusive environment
  • collaboration with cross-functional teams

Key Requirements

  • Bachelor's degree in life sciences, healthcare, business, or a related field
  • 3-6 years of experience in a Clinical Research environment
  • Relevant experience in site support, clinical administration, or similar roles
  • Good understanding of clinical trial processes, GCP, and site documentation requirements
  • Strong organizational and problem-solving skills
  • Excellent communication and interpersonal skills

Work Rights

Not specified

Tailored Resume

Cover Letter