Study Start Up Associate II

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.

Location: United States (Remote)

About the role

The Study Start Up Associate II will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. You will collect, prepare, review, approve, process, and track regulatory and site‑level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. This role is part of Accellacare, ICON’s clinical research network, focused on delivering better access, greater efficiency, and improved outcomes in clinical research.

Responsibilities

• 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.

Requirements

• 1+ years of clinical research experience in regulatory affairs, clinical research coordination, and/or study start‑up activities.
• Experience at a clinical research site (preferred).
• 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.
• Proactive approach with a strong willingness to learn and develop new skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross‑functional teams.
• Bachelor’s degree, preferably in a life sciences, healthcare, or related field.

Benefits

• Various annual leave entitlements.
• A range of health‑insurance offerings to suit you and your family’s needs.
• Competitive retirement‑planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme (LifeWorks) with 24‑hour access to a network of independent professionals.
• Life assurance.
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.