Clinical Research Documentation Administrator (TMF)

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration. 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.

Job Summary:

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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?:

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

 

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

 

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

 

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

 

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events and intramural sports

 

Cincinnati Headquarters Experience

• • A modern corporate campus designed to support collaboration and productivity
  • Multiple on-site dining options in the heart of Madison Square
  • Free on-site parking
  • Convenient access to on-site 24-7 fitness and wellness facilities

 

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.