Senior CTA

Clinical Trial Assistant assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives

• - Assists in coordination and administration of clinical studies from the start-up to execution and close- out.

  - Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

  - Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.

  - Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.

  - Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.

  - Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.

  - Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.

  - Contributes to the production and maintenance of study documents, ensuring template and version compliance.

  - Contributes  to   electronic  applications/submissions  by  handling   clinical-regulatory  documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

  #LI-MC6
  #LI-Remote

You are:

•  Previous CTA experience 

•  Good knowledge of spoken and written English 

• University diploma 

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.