Description
RESPONSBILITIES WILL INCLUDE but are not limited to:TMF Administration:
- Ensuring the filing of study documentation in the TMF in accordance with GCP
- Maintaining up to date departmental records & following up missing documents.
- Performing periodic quality control documents for accuracy and completeness.
- Assisting clinical staff with review and quality checks of TMF documents maintained by CRO partner
- Final reconciliation and archiving.
- Ensure TMF files are inspection ready
QA Document Administration:
- Provide QA administrative support
- Tracking QA documents for review and signature
- Issuing and tracking essential controlled documents including SOPs
- Updating SOP forms according to the documented process
- Maintaining an up to date, accurate file (manual and electronic) of all final SOPs and forms
- Assist with internal /external audit preparation files
General Clinical Department Administration
- Serve as a central contact for the clinical team for designated project communications, correspondence and associated documentation as assigned.
- Track publications and maintain listing of articles
- Prepare, handle, distribute and file clinical documentation and reports (paper and electronic)
- Maintaining records of all archived documents including content and location of boxes.
- Maintaining an up to date Master Archive File to record archive access and ensure files are readily available for inspection whenever required.
- Maintaining a constant awareness of the clinical teams activities
- Attending clinical project/study meetings. Preparing meeting minutes as required.
To find out more about Real please visit www.realstaffing.com