Site Specialist II (Remote)

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Site Specialist II for Georgia, working remotely. The role supports the preparation, process and tracking of site-level critical documents and site activation tasks required for site activation, in line with ICON SOPs/WPs, Sponsor SOPs, applicable regulations and ICH/GCP principles.

Key responsibilities

• Support Site Partners in collecting, reviewing, organising and assembling initial start-up and maintenance submission packages for Central EC/IRB, Local EC/IRB, Competent Authorities and other local regulators, in line with ICH/GCP and country regulations.
• Support the collection and assembly of documents for the Critical Document Package (CDP) and site activation, ensuring Sponsor and Investigator obligations are met.
• Coordinate the translations required for start-up documentation.
• Enter progress data on documents collected from sites and site activation activities accurately and on time into tracking systems.
• Take part in internal study review meetings to update study teams on document collection progress and completed activation tasks.
• Forecast site activation plans and follow up on them, keeping ICON's systems accurate.
• Ensure Trial Master File (TMF) documents submitted during start-up are complete and accurate, and run a quality control review before transfer to maintenance.
• Attend study team meetings as required and carry out other duties as assigned.

Required profile

• Bachelor's degree in life sciences or a related field.
• Very good English and the local language.
• At least 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up.
• Strong understanding of regulatory requirements for clinical trials, including ICH-GCP and local rules.

Required skills

• Knowledge of ICON SOPs/WPs, ICH/GCP and ICON systems.
• Excellent organisational and project management skills, able to prioritise multiple tasks.
• Excellent communication and interpersonal skills, able to work with cross-functional teams.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.