Mawdsleys
,
Doncaster, South Yorkshire
Clinical Trials Operational Administrator
Overview
Job Description
The Clinical Trials Operational Administrator role is to administer documentation for Clinical Trial orders & deliveries, ensuring a high quality service to clients is maintained, deadlines are worked to and activities are carried out in a timely and professional manner. The successful candidate will be expected to ensure a high quality service is maintained, deadlines are worked to, activities are carried out in a timely and professional manner, and where applicable ensuring compliance with Good Manufacturing Practice (GMP). Duties: Clinical Trials - Orders * Ensure the 'Order Status Log' is maintained up to date at all times, and all despatch and rolling orders are progressed and chased to ensure they are turnaround within agreed timeframes. * Prepare documentation for daily Clinical Trial Orders (Despatch & Rolling). * Process Job Bags for Rolling Orders, and track and chase these production to ensure turnaround times are maintained. * Close out and update of electronic system following completion of Rolling Orders, ensuring Clinical Trials Coordinators are updated when ready to be made available. * Liaise with Sites and Clients on a daily basis. * Liaise with Operation and Quality teams on a daily basis. * Process Temperature data following despatch and delivery of orders Clinical Trials - Incoming Deliveries * Coordination of incoming and received Investigational Medicinal Products and Non Investigational Medicinal Products, to ensure they are inspected, the system updated, manufacturers batch documentation is available, importation requirements have been assessed, an incoming Quality Assessment / Importation Certification has been performed by the Quality Team, and physical product transferred to a live location. * Coordination of incoming and received Returns, to ensure they are inspected, the system updated, an incoming Quality Assessment has been performed by the Quality Team, and physical product transferred to the appropriate location as instructed. * Ensure the 'Goods Receipt Tracker' is maintained up to date at all times, and all incoming and received deliveries are progressed and chased to ensure they are turnaround within agreed timeframes. * Ensure the Clinical Trials Coordinator is kept up to date on their trial deliveries. Clinical Trials - Stock * Performing stock takes of Investigational Medicinal Products and Non Investigational Medicinal Products. Monitoring stock levels and expiries. * Provide stock take reports to the Clinical Trials Coordinators and Manager. Other & General Duties: * Control the Clinical Trials inbox, identifying new orders and deliveries, monitoring notifications of delivery to receiving investigator sites and follow up. * Ensure charges are recorded against the correct clinical trial on a daily basis for services carried out. * PSF Administration as required by the Clinical Trial Coordinators. * Invoice Checking. * Complete complaints and deviation reports, when required. * Logging, scanning and filing. * Arranging courier collections as required. * Liaise with Internal Personnel, Clients and Contract Manufacturers on a daily basis. * Liaising with clients and others by telephone and email. * Training other staff members on duties involved with this role. * Any other duties as required by the Clinical Trials Manager. The person we are looking for will have: * A good standard of Maths and written and verbal English is required. G.C.S.Es A-C grade or the equivalent. * Basic computer skills, with experience of Word and Excel. * Ability to manage own workload, and work under own initiative. * Able to work with people of all levels. * Good organisational skills. * Ability to prioritise and keep to deadlines. * Good attention to detail. * Good Customer Service skills. * Ideally, you will have a background in clinical/healthcare/pharmaceutical.