# Site Specialist II

**Company**: ICON
**Work arrangement**: remote
**Experience**: mid
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Georgia-Tbilisi/Site-Specialist-II_JR158149?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1c7c4d51-bc9

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Site Specialist II, you will support preparation, process and tracking of site level critical documents and/or of site activation tasks required for site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP.

**Responsibilities**

- Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity

- Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities

- Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation

- Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools

- Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks

- Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems

- 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

- Attend study team meetings as required

- Other duties as assigned

**Requirements**

- Bachelor's degree in life sciences or a related field

- Very good knowledge of English as well as the local language

- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities

- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements

- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously

- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

**Rewards & Benefits**

- 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 wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- ICH-GCP
- regulatory affairs
- clinical research
- study start-up activities
- project management
- communication skills

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