Clinical Records Specialist
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 approximately 3,500 people across almost 40 countries.
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.
The Clinical Records Specialist 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.
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.
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Recognized by Forbes as one of America's Best Mid-size Companies in 2021
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
*WARNING:Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
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