Clinical Trial Management Associate

Job Description

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

Benefits

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)