Beschreibung
The CRA will be involved in most activities like in preparation for study set up, conduct and completing a Clinical Trial which usually includes:
- Manage documentation associated with clinical trials, both in paper and electronic format, including transitions and conversions.
- Follow records management tasks, policies and procedures protecting record integrity by ensuring full compliance to GCP principles and client SOPs.
- Perform audit and quality control checks on paper based studies and Electronic Data Capture systems.
- Experience in using electronic document management system (First Doc - Documentum), including QC approval of workflows and uploading
- Receive, process and track all clinical project related paper and electronic documents including global study and site documents
- Create and maintain filing structure for all the regulatory INDs, NDAs, CTAs, DMFs and SBAs
- Fulfill company-wide requests for documents, records, and study reports; Liaise with study teams to coordinate the flow of trial documentation to the Records Center
- Support project teams and functions in the preparatory activities for sponsor audits and regulatory inspections.
- Conduct and manage electronic Trial Master File (eTMF) processes and train staff and deliver presentations regarding eTMF policies and procedures to disseminate knowledge and increase compliance.
- Maintain logs and indexes to ensure information status is audit ready at all times and assist in the collection of data
- Manage and oversee the external archiving providers, including tracking of documents between Client and the external archive