Clinical Trial Assistant 2

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.

We are currently looking for an experienced Clinical Trial Assistant (CTA 2) to join our FSP team. This particular CTA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The Clinical Trial Assistant (CTA) supports Study Start-Up Manager and Clinical Project Manager in assigned studies during set-up and whole study lifecycle in compliance with sponsor's processes, GCP/ICH and regulatory requirements.

Responsibilities:

• • Supports document collection, preparation, and adaption for submission to IRB/EC and Health Authorities as applicable
  • Sets-up systems. supports vendor selection, etc
  • IF and TMF management (country and site TMF); set-up and maintenance according to regulatory requirements; document oversight and tracking
  • Supports preparation and translation of ICF into local languages (including vendor management if necessary)
  • Responsible for completeness of uploaded trial related documents into sponsor's systems, including archiving of paper TMFs
  • Supports country SSU strategy in close collaboration with SSU Team Lead and Managers to ensure SSU timelines and deliverables are met according to country commitments
  • Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
  • Provides logistic support to CRA, CPM, SSU Manager in all phases of the clinical trial

Requirements:

• Bachelor’s or MA Degree
• Minimum 6 months of experience in a Clinical Trial Assistant or a similar role in clinical trials
• A demonstrated working knowledge of ICH/GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Fluent in English & Polish

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/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.

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