Study Start Up Associate II

Study Start Up Associate II - United States (Remote)
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.
Location: United States (Remote)
What You Will Be Doing
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.
Your Profile
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
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
What ICON Can Offer You
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
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, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply

Work arrangement
Yes