Clinical Study Associate

As a Clinical Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

We are seeking a detail-oriented and proactive Clinical Study Associate (CSA) to join our US Medical Affairs team supporting Investigator Initiated Studies (IIS) across multiple molecules. In this role, you will provide critical operational support to the Clinical Study Manager and project team, ensuring timely and compliant execution of all study activities in accordance with sponsor SOPs, regulatory guidelines, and internal processes.

• Coordinate Study Review Team (SRT) meetings: prepare agendas, distribute minutes, and maintain documentation

• Manage proposal tracking, study number generation, and system entries 

• Support investigator onboarding, site file setup, and protocol documentation

• Coordinate CDA/contract execution, IND cross-referencing, and initial drug shipments

• Monitor enrollment, review regulatory documents, and manage protocol amendments

• Process invoices, drug reorders, and track study milestones across systems

• Perform routine QC of files and ensure compliance with naming conventions and filing timelines

• Collect and archive final site documents, complete study conclusion forms, and issue closure letters

• Close POs, update systems with closure milestones, and prepare files for long-term storage

• Coordinate with cross-functional teams as needed
  
  

You are:

• Bachelor's degree in business, finance, health sciences, or related field

• Nursing or Study Coordinator background with minimum 1 year of relevant experience preferred

• Working knowledge of Good Clinical Practices and clinical/regulatory operations

• Fluent in English (written and verbal)

• Previous experience with IIS, portal-based systems, and project administration

• Highly organized, detail-oriented, and able to prioritize with minimal supervision

• Strong problem-solving, risk mitigation, and data interpretation abilities

• Excellent communication skills with fluency in medical/scientific terminology

• Technically savvy with spreadsheets, portals, and study management tools

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.