Study Start Up Associate I

IRE

20h • Onsite

About The Position

IVDR Study Start-Up Associate - UK 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 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. At ICON, you will play a key role in the successful start-up and activation of In Vitro Diagnostics (IVD) clinical studies, helping to bring innovative diagnostic solutions and healthcare advancements to patients worldwide. As an IVD Study Start-Up Associate, you will partner with cross-functional teams, investigative sites, and regulatory stakeholders to ensure studies are initiated efficiently and in compliance with applicable regulations and timelines.

Requirements

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Previous experience in clinical research, study start-up, regulatory affairs, or site activation within a CRO, sponsor, or healthcare environment.
• Hands-on experience preparing and coordinating UK clinical study submissions
• Knowledge of applicable regulatory requirements and clinical research processes.
• Strong organisational skills with the ability to manage multiple priorities and timelines.
• Excellent communication and stakeholder management skills.
• Willingness to travel within the UK occasionally, approximately 5%.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Experience in In Vitro Diagnostics (IVD) studies is highly desirable.

Responsibilities

• Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions.
• Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation.
• Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents.
• Supporting study teams in the development, review, and management of key study documentation, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies.
• Tracking study start-up milestones and proactively identifying and resolving issues that may impact activation timelines.
• Ensuring all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level