Clinical Site Associate (In-House CRA)

Clinical Site Associate (In-House CRA)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing

• Site Support & Oversight: Manage site-level communications, coordinate site trainings and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items.

• Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness; perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable.

• Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF; assist with eCRF UAT testing and clinical sample tracking.

• Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements.

• Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations; support SAE and external data submissions and follow up.

• Site Relationship Management: Support the CRA in establishing and maintaining strong site relationships. CSA needs to understand site-specific processes, and act as a back-up point of contact for the CRA; or as a primary point of contact when needed.

• Demonstrates technical proficiency in clinical trial technologies, including electronic data capture (EDC) systems, clinical trial management systems (CTMS), and remote monitoring tools to streamline trial operations and ensure data integrity.

• Monitors key risks and alerts CRA and/or site when risk flags as concerning.

• Regulatory & Safety Support: Assist with safety reporting submissions, serious breach reporting, and due diligence checks for institutional/staff changes.

• May be required to travel <10% of time domestically.

• Fluent in English and local language, with good verbal and written communication skills.

Your profile

• Bachelor's degree in a relevant field, such as life sciences or healthcare

• Previous experience in clinical research or a related field preferred

• Strong organizational and communication skills

• Ability to work independently and collaboratively in a fast-paced environment

• Attention to detail and ability to prioritize tasks effectively

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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