Etmf Trial Master File Assistant - Boston, United States - Cardiovascular Clinical Studies

Cardiovascular Clinical Studies

Verified Company

Boston, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Trial Master File Assistant

Overview

Cardiovascular Clinical Science Foundation (CCSF) is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

CCSF specializes in Cardiovascular medicine, leveraging over 25 years of expertise in this therapeutic space to provide best in industry design and execution of Cardiovascular Clinical Development programs.

Job Summary

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 and efficiently.

Therefore, the documents within the TMF are important to the successful execution of a trial and ultimately plays a pivotal role in a new drug or device receiving approval by the FDA.

Responsibilities

The Trial Master File Assistant supports the TMF Specialist and Clinical Project Managers responsible for clinical trials by ensuring documents meet established quality standards.

This position involves independent, computer-based work, as well as communication and collaboration with trial teams.

Upload clinical trial related documents in an electronic filing system for multiple trials;
Track, maintain, and perform quality check of electronic documents;
Communicate with internal associates globally regarding errors in trial documents;
Participate in clinical trial team meetings

Qualifications