About the job
* Develop a foundational understanding of GCP, ICH, and GLP regulations related to the organization and preservation of clinical trial documentation and preclinical study records.
* Contribute to the ongoing security and upkeep of the Trial Master File (TMF) Room.
* Engage in offsite storage activities.
* Construct and manage study-specific file structures for clinical, biometrics, and preclinical documents, ensuring proper filing of all documents.
* Maintain accurate and up-to-date record filing.
* Conduct inventory reviews for incoming CRO clinical study files; receive, index, and file preclinical study records; oversee offsite archiving of documents; participate in regular reviews of file room utilization; file incoming documents and retrieve documentation from the TMF Room upon request.
* May assist in preparing for TMF-related inspections by regulatory agencies and internal GCP readiness assessments.
* Support the creation of electronic tracking and filing systems.
