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

Learn more about our EEO & Accommodations request here.