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 at ICON, you will independently manage a range of site support activities, acting as a key operational contact for sites and contribute to efficient study start-up and maintenance.
Key Responsibilities:
- Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies.
- Acting as an operational liaison for site staff on documentation, systems, and process-related questions.
- Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools.
- Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits.
- Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.
- Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.
Your Profile:
- Bachelor's degree in life sciences, healthcare or a related field, and clinical research experience.
- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities (local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees).
- 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, and to collaborate effectively with cross-functional teams in a fast-paced environment.
- Excellent communication skills both in English and Spanish.
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.