Entry-Level Trial Master File (TMF) Specialist
About The Position
We are currently hiring entry-level individuals seeking an exciting career in clinical research, managing our Trial Master File. The Trial Master File (TMF) is a collection of documents that stores all data and research collected on a given trial. The TMF allows us to conduct a clinical trial and ensures data integrity. It is an integral tool and helps teams manage trials more effectively. 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 will be working with a highly experienced team of administrators, specialists, and clinical research professionals that can help you grow your skillset while working for a growing and developing company. This position is office-based in Cincinnati, OH.
Requirements
- Bachelor's degree, life science field preferred
- Proficient knowledge of Microsoft® Office and Adobe Acrobat®
- Computer literacy (i.e., ability to file, scan, create folders, and organize files using various software)
- Ability to accurately and carefully follow procedures for completing work tasks
- Ability to perform repetitive work without losing effectiveness/accuracy
Responsibilities
- Provide guidance and support to study team members and sponsors regarding TMF management
- Initiate and manage TMF Specifications based on scope of work, protocol, and other core documents working with functional area leads and sponsor contacts
- Set up and maintain study specific TMF folder structure
- Support CTMs with review of TMF Plans as required
- Support study team(s) during periodic TMF QCs by assisting with report development and metric reporting
- Report on TMF Health to Sponsors and CTMs
- Contribute to audit/inspection readiness activities by reviewing the TMF, TMF Specifications, and TMF Plans for accuracy, consistency, and completeness
- Train and mentor other TMF staff
- Help with other project and responsibilities, as assigned
Benefits
- Flexible work environment
- Competitive PTO packages, starting at 20+ days
- Competitive compensation and benefits package
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- Structured career paths with opportunities for professional growth
- Discounted tuition for UC online programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
