Clinical Trial Coordinator - FSP Team - Madrid
PharmaCROClinical ResearchQuality Assurancecroctmsinform
Job description
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 .
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