Study Start Up Associate II (US/Canada)

About the role

ICON Strategic Solutions is hiring a Study Start Up Associate II for its North America region (United States and Canada). Working in a sponsor-dedicated model, the associate leads the initiation of clinical trials, ensures compliance with regulatory requirements and helps advance treatments that benefit patients worldwide.

Key responsibilities

• Lead site start-up and activation activities, taking responsibility for deliverables and working collaboratively.
• Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions and regulatory agency communications.
• Coordinate with internal and external stakeholders to obtain the approvals and authorisations needed for study initiation.
• Maintain accurate records of regulatory submissions, approvals and correspondence.
• Support study teams with guidance on regulatory requirements and best practices for study start-up.
• Take part in process improvement initiatives to streamline study start-up.

Required profile

• Bachelor's degree in life sciences or a related field.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up.
• Demonstrated experience in ethics submissions and managing the ethical review process for clinical studies at U.S. study sites.
• 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 at once.
• Communication and interpersonal skills for collaboration across functions.

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.