Clinical Research Documentation Administrator (TMF)

• We are currently hiring 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 other administrators and clinical research professionals that can help you grow your skillset while working for a growing and developing company. *This position is fully office-based in Cincinnati, OH.

Responsibilities

The Clinical Research Documentation Coordinator 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

Associates degree, or equivalent required; Bachelor's degree preferred; Some experience in document administration; High attention to detail; Excellent organizational skills Strong written and verbal communication skills; and Knowledge of MS Office.

Medpace Overview

• Medpace is a full-service clinical contract research organization (CRO).
• We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
• Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
• We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
• Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.