Clinical Trial Administrator

Quotient Sciences•Miami, FL

2d•Onsite

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

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.
Must be aged 18 years or over.
Must not have been debarred by the FDA.

Nice To Haves

Relevant work experience in a pharmaceutical company/CRO would be an advantage.

Responsibilities

Provide administrative support for the Project Management group.
Lead study review activities and communications on allocated projects.
Comply and adhere to GCP guidelines and regulations as required of this role.
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.