Site Specialist II - Georgia - RemoteICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Site Specialist II supports 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.
What you will be doing?
Recognize, exemplify and adhere to ICON's values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.
Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
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, 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/or 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.
Support coordination of all necessary translations required for any start-up documentation.
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 and proactively follow through for achievement to plan.
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
Your profile:
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
