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 and adherence to applicable GCP guidelines and regulations. It includes preparing and maintaining study documentation and trial master files, supporting regulatory submissions and study closeout, maintaining study and volunteer records, assisting with data and eSource activities, and supporting sponsor monitors during site visits. The work may involve very high concentration, strict and tight deadlines, managing multiple tasks and issues simultaneously, working in a hazardous environment with a high requirement to follow safety procedures, working outside normal hours, and responding to client demands.

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.
People-oriented personality.

Nice To Haves

Relevant work experience in a pharmaceutical company or CRO.

Responsibilities

Assist in 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 paper and electronic TMF quality control (QC).
Set up and file documents in client Trial Master Files, electronically or on paper, when requested.
Coordinate with internal teams to maintain accurate and timely delegation logs for new and terminated staff.
Maintain training logs and ensure training compliance for personnel listed on delegation logs.
Manage file note control, including creating, reviewing, and filing file notes.
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 of updated or newly released documents through secure file systems.
Assist with study closeout activities, including archiving.
Maintain and perform QC of the volunteer clinical RSVP database.
Manage laboratory requisitions and collaborate with Data Management to support query resolution.
Support eSource User Acceptance Testing (UAT) activities.
Set up admission binders.
Break down files ready for archiving.
Assist with hosting and supporting sponsor monitors during site visits and with related action items.
Perform other duties as assigned.