Clinical Trial Management Associate

Job Summary

A company is looking for a Clinical Trial Management Associate (Contract).

Key Responsibilities

• Support operational aspects of clinical trials, including study start-up, IRB submissions, enrollment, maintenance, and close-out
• Conduct study tracking activities and assist with the development and oversight of essential clinical documents
• Manage vendor performance and assist with the oversight and maintenance of the study's Trial Master File (TMF)

Required Qualifications

• Minimum requirement of a BA/BS or equivalent degree
• Clinical research experience, preferably in cell therapy and/or oncology
• Knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
• Experience with TMF maintenance and management
• Ability to work independently and as part of a team