Site Specialist II - Clinical Research

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Site Specialist II, you will independently manage a range of site support activities and act as a key operational contact for sites, helping with efficient study start-up and maintenance. You will take responsibility for site management and operations deliverables, ensuring quality and efficiency.

Key responsibilities

• Coordinate site-level document collection, review and maintenance, ensuring accuracy and compliance for assigned sites or studies.
• Act as an operational liaison for site staff on documentation, systems and process questions.
• Maintain up-to-date site status, metrics and key milestones in clinical trial management tools.
• Support planning and logistics for site meetings, investigator meetings and monitoring visits.
• Identify opportunities to streamline site workflows and contribute to process improvement.
• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions and regulatory agency communications.
• Liaise with internal and external stakeholders to obtain approvals and authorisations for study initiation.
• Maintain accurate records of regulatory submissions, approvals and correspondence.
• Guide study teams on regulatory requirements and best practices for study start-up.

Required profile

• Bachelor's degree in life sciences, healthcare or a related field.
• Clinical research experience, with at least 2 years in clinical research or regulatory affairs.
• Specific experience in study start-up, including local and/or international regulatory processes and submissions to regulatory authorities and ethics committees.
• Legal right to work in the country where the role is based.

Required skills

• Strong understanding of regulatory requirements and guidelines, including ICH-GCP and local regulations.
• Organizational and project management skills, able to handle multiple tasks and work with cross-functional teams.
• Excellent communication skills in English and Spanish.

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.