Clinical Trial Administrator
Miami, FL, United States3d ago
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Key details
- Location
- Miami, FL, United States
- Work style
- Onsite
- Function
- Healthcare
- Focus area
- other
- Posted
- 3d ago
Skills
gcpmicrosoft windowsquality control
About the role
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
#INDHP
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
#INDHP