Project Assistant, Documentation Management

Overview

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.

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

• 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

Benefits of Working in ICON: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.At 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.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, 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.