Document Specialist II
Posted 9hrs ago
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Job Description
Document Specialist II maintaining clinical trial documents and TMF records for Fortrea. Managing filing, reconciliation, archiving, quality checks, and eTMF training.
Responsibilities:
- Maintain and archive documents produced by the CPS Project Management Team
- Organize, gather, scan, file, and ship project documentation
- File TMF documents for CPS PM, non-Fortrea sites, and the Fortrea P1MS Clinical Monitoring Team
- Generate document queries and perform file reconciliation and resolution activities
- Maintain standardized filing structures, departmental files, tracking forms, and spreadsheets
- Assist with TMF Plan and Index review and finalization
- Assist with TMF project setup and closeout processes
- Retrieve, file, and upload documents in accordance with milestones, timelines, SOPs, policies, systems, and client requirements
- Interact with project teams to secure missing TMF documents and follow up on document quality issues
- Perform TMF reconciliation as part of quality control
- Generate copies of project data for archival or client delivery
- Lead and perform paper and electronic archiving duties
- Provide metric data and perform departmental or project administrative tasks
- Train and mentor new Document Specialists and develop, review, and revise training materials
- Serve as a TMF Subject Matter Expert and train team members on eTMF systems and processes
- Perform other duties as assigned
Requirements:
- High School Diploma or equivalent at minimum
- BS or equivalent in scientific field preferred
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Strong written and verbal communication skills in English
- Experience working with computers and basic programs, including Adobe Acrobat, Word, Excel, and PowerPoint
- Strong organizational skills and ability to work in a fast-paced setting with many interruptions
- Must be able to sit at a computer for long periods
- Must be able to use hands to finger, handle, or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day
- Risk of eye strain
Benefits:
- Remote work arrangement
- Standard office and/or home working environment
- Training and mentoring opportunities
- Opportunity to train and mentor new Document Specialists
- Potential work outside normal office hours as required by the role
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