Clinical Trial Administrator

Quotient Sciences•Miami, FL

About The Position

The Clinical Trial Administrator provides administrative support to the Project Management group and leads study review activities and communications on allocated projects. The role requires compliance with applicable Good Clinical Practice (GCP) guidelines and regulations. The position supports study documentation, trial master file (TMF) setup and maintenance, quality control, regulatory submissions, staff training and delegation records, study closeout and archiving, and sponsor monitor visits. It also involves supporting laboratory requisitions, data queries, and eSource user acceptance testing.

Requirements

High school diploma or equivalent.
Computer literate and proficient in Microsoft Windows.
Proficient in information technology.
Highly organized and efficient.
Ability to communicate effectively and a people-oriented personality.
Must be aged 18 years or over to work in the organization.
Must not have been debarred by the FDA.

Nice To Haves

Relevant work experience in a pharmaceutical company or CRO.

Responsibilities

Assist with preparing and formatting study documentation, including informed consent forms, source documents, and client deliverables.
Set up and maintain Investigator Site Files and electronic Trial Master Files (eTMFs).
Complete and initiate quality control of paper and electronic TMFs.
Set up and file documents in client Trial Master Files, electronically or on paper, when requested.
Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff.
Maintain training logs and ensure training compliance for personnel listed on delegation logs.
Manage file note control, including creation, review, and filing.
Ensure regulatory documentation is audit-ready and compliant with archiving requirements.
Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
Process Spanish regulatory documents and communicate approvals to the screening team.
Notify staff about updated or newly released documents through secure file systems.
Assist with study closeout activities, including archiving.
Maintain and perform quality control of the volunteer clinical RSVP database.
Manage laboratory requisitions and collaborate with Data Management to support query resolution.
Support eSource User Acceptance Testing activities.
Set up admission binders.
Break down files ready for archiving.
Host and support sponsor monitors during site visits and assist with related action items.
Perform other duties as assigned.