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Clinical Document Specialist
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Clinical Document Specialist
About the RoleWe are seeking a highly organized and detail-oriented Clinical Document Specialist to join our global Clinical Pharmacology Services team. As a Clinical Document Specialist, you will be responsible for maintaining and organizing clinical documents related to our projects, ensuring that all documentation is accurate, complete, and compliant with regulatory requirements.
Key Responsibilities- Responsible for general maintenance and archival of documents produced by study project teams within CPS.
- Organizing, gathering, scanning, and filing of all applicable documents into appropriate electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Fortrea SOPs or other applicable directive.
- Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications, as well as to meet project timelines and productivity targets.
- Maintains an internal standardized filing structure for study-related documents.
- Works directly with the assigned Study Project Manager (PM) to review and finalize the TMF Plan and Index for individual projects.
- Creates and/or maintains any general document/file-related tracking forms and/or spreadsheets, as applicable.
- Any experience within an administrative or IT-focused role within clinical trials or a hospital/medical setting would be advantageous. Full training will be provided.
- Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, PowerPoint).
- High School Diploma or equivalent.
- Strong written and verbal communication skills (English language).
- Strong organisational skills, with the ability to work in a fast-paced setting with many interruptions.
$60,000 - $80,000 per year
About UsFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Why Work with Us?We offer a dynamic and supportive work environment where you can grow and make an impact on a global scale. Our commitment to diversity, equity, and inclusion ensures that everyone feels valued and respected. Join us and become part of a talented team that shares your passion for breaking down barriers faced by sponsors of clinical trials and helping transform the development process to get promising life-changing ideas and therapies to patients faster.
