Clinical Trial Coordinator - FSP Team - Madrid

Job Overview:

The Clinical Trial Coordinator is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.

Summary of Responsibilities:

Document and track study activities using relevant forms and tools, as well as relevant Project

Management Systems with guidance/support.

Assist in the preparation of study and site-specific materials in accordance with relevant SOPs.

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

as requested.

Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies.

Maintain the Project Directory.

Provide support for Investigator Meetings; track meeting attendees and/or other information

regarding the Investigator Meeting.

Provide support to project team (e.g., proof-reading and editing correspondence, mailings,

shipping ofstudy files, faxing and photocopying documents, assembling study documents, and

arranging meetings, etc.).

Maintain Trial Master File documentation within the appropriate TMF platform, participate in

TMF QC, as assigned, and track and /archive as applicable.

Audit and CAPA tracking.

Set up and maintain clinical investigator files and documentation.

Liaise with vendors, as needed, for study conduct such as printing study materials and/or

external systems access for study team members.

Coordinate and plan study supply shipments with vendors.

Maintain and confirm shipment information such as courier tracking numbers and

date of shipping and delivery.

Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other

study-specific ancillary supplies (i.e., diary cards, patient visit reminders).

Generate reports as needed, for example CTMS site contact information list.

Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical

Trial Lead.

Qualifications(Minimum Required):

Diploma – Associate degree or equivalent.

In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Language Skills Required: Speaking: English and local language

Experience (Minimum Required):

Minimum one (I) year administrative experience or equivalent training.

Good oral and written communication skills.

Good organizational and time management skills.

Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)

Preferred:

Aptitude for handling and proof-reading numerical data, some spreadsheetsoftware

competency

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