Clinical Document Coordinator

hace 3 semanas


Xico, México Fortrea A tiempo completo

Fortrea is seeking a skilled Clinical Document Coordinator to join our team. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions.

Key Responsibilities:

Maintain and archive documents produced by study project teams within our Clinical Project System (CPS).

Organize, gather, scan, and file all applicable documents into electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Fortrea SOPs or other applicable directives.

Generate document queries and resolve file reconciliation activities to support delivery of the TMF to client quality and integrity specifications.

Maintain an internal standardized filing structure for study-related documents.

Collaborate with Study Project Managers to review and finalize the TMF Plan and Index for individual projects.

Create and/or maintain document/file-related tracking forms and/or spreadsheets, as applicable.

Maintain the TMF by working with project team members to retrieve, file, and upload documents in accordance with applicable SOPs, policies, systems, and client requirements.

Interact with project teams to secure documents for the TMF and follow up on missing documents, as needed.

Perform archiving duties for all paper and/or electronic media, as needed.

Maintain departmental files, including project files.

Requirements:

Experience in an administrative or IT-focused role within clinical trials or a hospital/medical setting is advantageous.

Strong written and verbal communication skills in English.

Strong organizational skills, with the ability to work in a fast-paced setting with many interruptions.

Fortrea is an Equal Opportunity Employer and welcomes applications from diverse candidates.



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