Electronic Trial Master File (eTMF) Intern

Purpose/Scope:

The QMC Intern reports directly to the Director of Quality Management & Compliance (QMC) and is responsible for assisting the QMC department in administrative tasks, with a primary assignment to support the electronic Trial Master File (eTMF). Additional projects may be assigned. The position will be based at our Boston Office.

Role and Responsibilities

• Under the immediate supervision of the eTMF Administrator, provides support for the AFT eTMF activities.
• Assists study teams with eTMF quality control and reconciliation of study documents to address documentation gaps.
• Assists the eTMF Team in retrieving reports necessary for assessment of eTMF metrics

• Performs a broad variety of special projects and administrative tasks as directed and required for the support of the assigned department, QMC.

Requirements

Qualifications and Education Requirements

• Recent Graduate or College Student enrolled in an accredited college course in the study of Health Care Administration or Management or relevant field.

• Familiarity with the eTMF Reference model and a demonstrated understanding of records management best practices preferred

Required Skills:

• Comfortable with technology and ability to learn new systems quickly
• Strong organizational skills and ability to handle multiple tasks
• Strong research, critical thinking and subject analysis skills
• Strong written and oral communication skills
• Proficiency in Google and Microsoft 360 applications
• Ability to work with others as well as independently
• High Speed Internet Connection
• Fully COVID Vaccinated