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

Responsibilities:

Establish and maintain the Trial Master File (TMF) in inspection-ready state
May communicate directly with sites to drive collection and review of essential documents throughout the study
Ensure accurate and timely review and filing of clinical trial related materials
Assist QC reviews of study, country, and site files, including issue resolution
Produce reports and status metrics as requested
Establish and maintain the Clinical Trial Management System (CTMS)
Maintain accurate and up-to-date site, vendor and internal study team contact information
Track study progress and produce reports and status metrics as requested
Assist Investigational Product reconciliation activities
Assist study team by performing administrative tasks as needed
Schedule meetings, either onsite or remote by means of virtual conferencing system
Prepare meeting agendas, minutes, and track action items
Operate and navigate within clinical trial systems including but not limited to Electronic Data Capture (EDC), SharePoint Online, eTMF and CTMS
May assist with the creation and maintenance of documents and plans for assigned clinical studies, including but not limited to training materials, study binders, plans, presentations, and reports
Ensure timely distribution of clinical trial related materials
Assist in activities associated with company-sponsored site quality audits as well as regulatory authority inspections
Works under general supervision in performing regular job duties and receives general instructions on new assignments
Assist in vendor oversight and vendor contact management.
Performs all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, and other applicable guidelines.

Qualifications:

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.