Project Coordinator - Leicester
Star is looking for a Project Coordinator to bring about the management, administration and maintenance of Clinical Trial programmes, particularly with reference to Good Clinical Practice, and to ensure that Trial Documentation is maintained in an orderly and compliant manner to support all trials (prospective, ongoing or archived).
- Set up and maintain clinical investigator files and documentation
- Prepare investigator budget payments and tracking systems; generate tracking reports as assigned
- Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Prepare monitoring visit documentation for Clinical Research Associates/Monitors and above, as requested by supervisor
- Prepare study-related documents and other materials for delivery to archives, at appropriate intervals
- Provide clerical support to project team (e.g., assemble study documents, arrange meetings, shipment of study files, proofreading and editing correspondence, etc.)
- Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements, and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
- Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly
- Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices
- Demonstrable experience of GCP, Clinical Trials and management and maintenance of trial documentation
- Competent understanding of clinical trials regulations (i.e. ICH, Clinical Trials Directive 2001/20/EC, GCP Directive 2005/28/EC)
- Solid understanding of quality systems
- Experience of implementing new systems and processes
- Competency and experience using Microsoft Office (e.g. Excel, Access & word) and electronic Quality Management Systems (e.g. Q-Pulse, Trackwise)
To apply for this role, contact Will Evans on or apply through this website.
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.
- Clinical Research
- Clinical Trials
- Project Manager