Clinical Trial Submissions Coordinator- Mexico Medpace 16 sep

Description

Medpace is a global, full-service contract research organization (CRO), headquartered in Cincinnati, OH, that provides comprehensive clinical research support to the pharmaceutical industry. In over 15 years of existence, we have grown to become a global company with operations in almost 40 countries and now have the reach to conduct clinical trials worldwide. While continuing to maintain a strong presence in Cincinnati, Medpace was named one of the fastest growing private companies in North America for 2007 by Inc.com. For more information, please visit our website at Medpace.com.

Responsibilities:

We are currently seeking individuals with excellent computer (word-processing, databases, spreadsheets, Windows), organizational and communication skills to join our Clinical Trial Submissions Team. Some of the responsibilities will include distributing, tracking, reviewing and approving individual site master file (TMF) essential documentation; collecting, reviewing, organizing, and assembling regulatory start-up submissions; maintaining timelines for study start-up; working with and providing guidance to internal and external team members (US office, as well as Latin America); reviewing submitted documents and ensuring they are present in the Document Center; preparing package documents for initial site submission, including review of the ICF template to ensure it meets local requirements, as well as work with the sites for changes requested on the ICF; and developing local processes/ guidelines for the region.

Requirements

Requirements:

The ideal candidate must have a Bachelorâ€^TMs degree, preferably in Life/Health Sciences. For this position, we will need an individual that is fluent in Spanish and English, possessing advanced oral and written communication in both. They should have prior experience in clinical research and regulatory affairs. Hands-on experience preparing, reviewing and submitting regulatory documentation is preferred. Very good organizational skills are needed for this position.

Other Information:

This position will be home-based until Medpace opens an office in Mexico, most likely in the area of Mexico City. Non-local travel will be involved, especially since this associate will be working with other Medpace employees in Latin America and the United States.

Medpace offers a competitive compensation and benefits package, including bonuses based on individual and company performance.