Clinical Trial Administrator

Quotient Sciences•Miami, FL

1d•Onsite

About The Position

Responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects. To comply & adhere to GCP guidelines and regulations as required of this role.

Requirements

Minimum Degree qualification or equivalent
Computer literate, 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/CRO would be an advantage

Responsibilities

Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables.
Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats.
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 all personnel listed on delegation logs.
Manage file note control, including creation, review, and filing.
Ensure all 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 via secure file systems.
Support the Project Management team with PSA activities, revenue forecasting, and invoicing.
Assist with study closeout activities, including budget reconciliation and archiving.
Maintain and perform quality control (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.
Assist with the hosting and support of sponsor monitors during site visits and with related action items.