Trial Master Files Representative
About The Position
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in the clinical research industry, currently has an opportunity for a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based position and may be filled from any US geography. In this position, you will be be involved in the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will be responsible for maintenance of the TMF, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements.
Requirements
- Bachelor's degree in related field such as science, nursing, or other biomedical discipline
- Experience in clinical research and/or Trial Master Files preferred
- Minimum 1 year document management experience.
- Excellent interpersonal and oral/ written communication skills.
- Highly organized and collaborative.
- Proficient computer skills, i.e., MS Word, Excel, PowerPoint.
- Ability to manage multiple priorities
Nice To Haves
- Experience in clinical research and/or Trial Master Files preferred
Responsibilities
- preparation and the completeness of the Trial Master Files (TMF)
- maintenance of the TMF, creating a file structure and indexing contents
- communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
