Document Specialist I

Job Overview:

Responsible for general maintenance and any required archival of documents produced by the CPS Project Management Team. 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.

Qualifications (Minimum Required):

• Lifesciences graduate with 0 - 1 years of experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required: Speaking: English Writing/Reading: English

Summary of Responsibilities:

• Maintains an internal standardized filing structure for study-related documents.
• Works directly with the assigned Project Manager (PM) and Project Coordinator (PC) 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.
• May interact directly with project teams in securing documents for the TMF, as appropriate.
• May interact directly with project teams to follow up regarding missing documents, as appropriate.
• Works with the PM/PC involved project teams, and applicable business partners for reconciliation of the TMF as part of the quality control process.
• May generate and deliver requested CD copies for clients and archive projects.
• Performs archiving duties for all paper and/or electronic media, as needed.
• Maintains departmental files including, but not limited to, project files.
• Performs other departmental administrative tasks, as assigned.
• All other duties as needed or assigned.

Experience (Minimum Required):

• Strong written and verbal communication skills (English language).
• Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, PowerPoint).
• Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions.

Physical Demands/Work Environment:

• Must be able to sit at a computer for long periods of time.
• 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.
• Standard office and/or home working environment.
• Risk of eye strain.
• Will involve out of normal office hours as required by the role.

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