Clinical Trial Administrator

Quotient Sciences; Miami (FL); On-site; USD 52,000 - 76,000; Full time

Job summary

Quotient Sciences in Miami is seeking a Clinical Trial Administrator to provide administrative support for the Project Management group and lead study review activities in a GCP‑compliant environment.

The role includes maintaining IIS/eTMF, logs, and filing, coordinating with internal teams, and assisting monitors during site visits to ensure audit readiness and archiving accuracy.

Qualifications

• High School Diploma or equivalent.
• Experience in pharmaceutical company or CRO is a plus.
• Proficient with Microsoft Windows and IT systems.
• Strong organizational and communication skills.

Responsibilities

• Assist in preparing and formatting study documentation (consent forms, source docs, client deliverables).
• Investigator Site File and eTMF set up and maintenance.
• Maintain delegation logs and training records, ensuring compliance.
• Complete TMF QC (paper and electronic) and filing into Trial Master Files.
• Archive regulatory documents and support study closeout activities.
• Assist sponsor monitors during site visits and related action items.

Skills

Communication skills

Organizational skills

Attention to detail

Team collaboration

Education

High School Diploma or equivalent

Tools

Microsoft Windows

Job description

The Role

• The Clinical Trial Administrator, is 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

Main Tasks and Responsibilities

• Assist in the preparation and formatting of study documentation, including but not limited to informed consent forms, source documents, and client deliverables.
• Investigator Site File and eTMF set up and maintenance
• Complete and initiate TMF QC (paper and electronic)
• Set up and filing into client Trial Master Files (electronic or paper) where requested by clients
• 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.
• Assist with study closeout activities, including 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.
• Set up of admission binders
• Breakdown of files ready for archiving
• Assists with all other duties as assigned
• Assist with the hosting and support of sponsor monitors during site visits and with related action items

Job Demands

The job may involve the following:

• Very high concentration of work
• Strict and tight deadlines
• Having to juggle a range of tasks/issues simultaneously
• Working in a hazardous environment with high requirement to follow safety procedures
• Working outside normal working hours
• Needing to respond to client demands

The Candidate

• High School Diploma or equivalent
• Relevant work experience in a pharmaceutical company/CRO would be an advantage
• Computer literate, proficient in Microsoft Windows
• Proficient in Information Technology
• Highly organized and efficient
• Ability to communicate effectively; people-oriented personality

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