Clinical Trials Administrator - Fixed Term

CK Group is recruiting for a Clinical Trial Support Assistant to join a clinical research organisation in the pharmaceutical industry at their site based in Macclesfield on a 12 month Fixed term contract.

Clinical Trial Administrator:

The mainpurpose of the role will be to:

• Support the clinical trial activities on behalf of the client with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulations
• Set up and maintain the documentationfolders associated with product development and the Trial Master File (TMF) in compliance with ICH-GCP
• Ensure the TMF index is kept up to date
• Coordinate the collection of essential documents during site set-up
• Assist in the development of processes and procedures in order to ensure that robust forecasting and scheduling of trials occurs
• Assist the Project Managers in the production of study reports and updates as required
• Set up trial specific meetings, taking minutes and tracking screening and enrolment across clinical sites
• Track and process investigator site payments
• Manage the clinical trial supplies for a study, including the tracking and shipment of materials e.g. lab kits
• Assist the project team with preparation and shipment of clinical trial documentation including: Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.
• Update and maintain trial tracking systems in accordance to the demands of the study e.g. investigational product tracking, payment tracking, monitoring visit tracking etc.
• Serve as an office-based point of contact for all sites during the trial
• Develop and maintain good working relationships with Investigators and study staff
• Assist with corporate administration activities according to need and availability

Your Background:

• Degree or equivalent qualification in life sciences or nursing
• A good understanding of ICH-GCP and regulatory requirements
• Sound knowledge of theclinical trial processes and procedures including regulatory standards
• Proven track record in working within clinical research in the pharmaceutical, CRO or NHS environment
• Experience in maintaining Trial Master Files/Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).
• Ability to work collaboratively with others, influencing and managing conflict
• Willingness and ability to travel domestically (and occasionally internationally) asrequired
• Excellent verbal and written communication and interpersonal skills
• Strong organisational and time management skills with an ability to multi task and work independently
• Strong technical skills using PowerPoint, Excel and Word

Entitlement to work in the UK is essential. For more information or to apply for this Clinical Trials Administrator position, please contact Steve Lord on 01246 457733 or email slord@ckclinical.co.uk. Please quote reference 51616.