Study Start Up Associate II

ICON plc • Blue Bell, SD

1d • Remote

About The Position

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. We have an incredible opportunity for a Study Start Up Associate II to join ICON’s Accellacare Site Network team. 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 with Accellacare, part of ICON's clinical research network, where you’ll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research.

Requirements

• 1+ years of clinical research experience in regulatory affairs, clinical research coordination, and/or study start-up activities
• 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
• Demonstrates a proactive approach and 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

Nice To Haves

• Experience at a clinical research site (preferred)

Responsibilities

• 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.

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