Study Start Up Associate II

IRE

3d

About The Position

Study Start Up Associate II (Supporting North America Region - US/CAN) At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Requirements

• 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 activities.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Demonstrated experience in ethics submissions and management of the ethical review process for clinical studies conducted at study sites in the United States is required.
• 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.
• Must have the legal right to work in the country where the role is based.

Nice To Haves

• This role supports the North America region (U.S. and Canada).

Responsibilities

• Contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.
• Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.

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: Mid Level