1 day ago

Clinical Trial Administrator (CTA)

Fortrea

Leiden

1 day ago

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The Clinical Trial Administrator (CTA) is a key member of a Clinical Project Team responsible for executing clinical research projects, performing study-related tasks, and maintaining documentation in compliance with regulatory standards. The role requires administrative experience, organizational skills, and proficiency in Microsoft Office. The position is based in Leiden, South Holland, Netherlands, and is on-site with minimal travel.

On-siteFull-timeEntry LevelMicrosoft Office SuiteMicrosoft Word

Clinical Trial Administrator (CTA)

Apply

On-siteFull-timeEntry LevelMicrosoft Office Suite

Salary

Not specified

Work Location

Leiden, South Holland, Netherlands, NL

Work Model

On-site

Experience Required

1 years

Employment Type

Full-time

Experience Level

Minimum one year administrative experience or equivalent training

Core Qualifications

Technical (Must-have)

Microsoft Office SuiteMicrosoft WordMicrosoft ExcelMicrosoft PowerPointspreadsheet softwaretypingproof-readingdocumentationTrial Master FileCTMSProject Management Systemscommunicationorganizational skillstime managementmathematical aptitude

Soft Skills

good oral and written communicationgood organizational skillstime managementattention to detailability to work in matrix environment

Key Responsibilities

•Document and track study activities using relevant forms, tools, and Project Management Systems.
•Assist in preparation of study and site-specific materials per SOPs.
•Complete minute taking and documentation for sponsor/external or internal teleconferences.
•Assist in setting up and maintaining tracking systems/spreadsheets for study supplies.
•Maintain the Project Directory.
•Provide support for Investigator Meetings; track attendees and information.
•Provide support to project team (proof-reading, editing, mailing, shipping, assembling documents, arranging meetings).
•Maintain Trial Master File documentation, participate in TMF QC, and track/archive as applicable.
•Audit and CAPA tracking.
•Set up and maintain clinical investigator files and documentation.
•Liaise with vendors for study conduct (printing materials, external systems access).
•Coordinate and plan study supply shipments with vendors.
•Maintain and confirm shipment information (courier tracking numbers, dates).
•Prepare/assemble/ship supplies to sites pre-SIV (Study File Notebooks, CRFs, ancillary supplies).
•Generate reports (e.g., CTMS site contact information list).
•Work with In-House CRA on data reconciliation with CTMS.
•General communications to sponsors, sites, internal team members via email, courier, or telephone.
•Perform other administrative duties as assigned by Line Manager, Project Managers, or Clinical Trial Lead.

Clinical Trial AdministratorClinical ResearchPharmaceuticalCRORegulatory ComplianceDocumentationMicrosoft OfficeEntry LevelLeidenNetherlands

Core Qualifications

Technical (Must-have)

Soft Skills

good oral and written communicationgood organizational skillstime managementattention to detailability to work in matrix environment

Key Responsibilities

•Document and track study activities using relevant forms, tools, and Project Management Systems.

•Assist in preparation of study and site-specific materials per SOPs.

•Complete minute taking and documentation for sponsor/external or internal teleconferences.

•Assist in setting up and maintaining tracking systems/spreadsheets for study supplies.

•Maintain the Project Directory.

•Provide support for Investigator Meetings; track attendees and information.

•Provide support to project team (proof-reading, editing, mailing, shipping, assembling documents, arranging meetings).

•Maintain Trial Master File documentation, participate in TMF QC, and track/archive as applicable.

•Audit and CAPA tracking.

•Set up and maintain clinical investigator files and documentation.

•Liaise with vendors for study conduct (printing materials, external systems access).

•Coordinate and plan study supply shipments with vendors.

•Maintain and confirm shipment information (courier tracking numbers, dates).

•Prepare/assemble/ship supplies to sites pre-SIV (Study File Notebooks, CRFs, ancillary supplies).

•Generate reports (e.g., CTMS site contact information list).

•Work with In-House CRA on data reconciliation with CTMS.

•General communications to sponsors, sites, internal team members via email, courier, or telephone.

•Perform other administrative duties as assigned by Line Manager, Project Managers, or Clinical Trial Lead.