Clinical Document Specialist
hace 4 semanas
Clinical Document Specialist Opportunity
Fortrea is seeking a Clinical Document Specialist to join the global Clinical Pharmacology Services team. This role involves working with project teams to maintain and archive documents produced during clinical trials.
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).
- Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications.
- 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.
- Maintains the TMF by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable SOPs, policies, system, and client requirements.
Requirements
- Any experience within an administrative or IT-focused role within clinical trials or a hospital/medical setting would be advantageous.
- 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 organizational skills, with the ability to work in a fast-paced setting with many interruptions.
About Fortrea
Fortrea 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 a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
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