Clinical Trial Assistant
1 week geleden
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.
The Clinical Trials Associate is responsible for assisting clinical study teams in the execution of clinical trials and on-time delivery of clinical trial milestones.
**What you will be doing**:
- 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.
- This position may involve travel for training or study needs, as applicable.
- ** You are**:
- A minimum of 1-year clinical operations experience, preferably within the pharmaceutical or biotechnology industry (global experience preferred)
- Basic knowledge and understanding of Essential Documents, CFR and/or GCP/ICH
- Proficiency with technological systems (Microsoft Office, Excel, PowerPoint, SharePoint Online, eTMF and CTMS (Veeva Vault Clinical preferred), EDC (Electronic Data Capture), Zoom, OneNote)
- Fundamental understanding of filing systems and organizational tools
- BS/BA or equivalent preferred, or relevant and qualifying training/experience
- Fluently Dutch and English
- ** 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
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