Entry Level Document Administrator
Job Summary
We are currently hiring individuals for an exciting career in clinical research managing our Trial Master File. The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical trial, and the integrity of the data produced, to be evaluated by regulatory bodies, such as the FDA. The TMF is an important tool and can help teams manage trials more effectively. Therefore, TMF oversight is important to the successful execution of a trial and ultimately plays a big role in a new drug or device receiving approval by the FDA. In this position, you would be working with a highly experienced team of other administrators and clinical research professionals that can help you grow your skillset while working for a growing and developing company.
Responsibilities
The TMF Document Administrator supports TMF oversight for a trial by ensuring documents meet established quality standards. This position involves both independent and computer-based work, as well as opportunity for communication and collaboration with trial teams.
- Manage electronic filing system for trial documentation;
- Track, maintain, and perform quality check of electronic documents;
- Communicate with internal associates globally regarding errors in trial documents; and
- Prepare documents for shipment.
Qualifications
- High school diploma, or equivalent;
- Some experience in document administration;
- High attention to detail;
- Excellent organizational skills
- Strong written and verbal communication skills; and
- Knowledge of MS Office.