Clinical Trials Administrator
Amy Lloyd is currently recruiting for a Clinical Trials Administrator to join a specialist UK-based CRO with particular expertise in oncology, rare diseases and advanced, cell and gene therapies - eTMF experience is essential.
The position is full time, permanent and located in Cheshire.
Description: The Clinical Trials Administrator is responsible for providing the administrative support to the clinical development/project teams and maintaining a range of clinical documentation. The person in this position will work closely with project teams to ensure that Clinical Trial Administration is performed in line with ICH-GCP allowing successful delivery of trials whilst protecting subjects' rights, safety and wellbeing and the production of reliable clinical trial data.
- Support the clinical trial activities with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulations.
- Set up and maintain the documentation folders 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.
Essential Requirements/Education and Experience:
- Degree or equivalent qualification in life sciences or nursing.
- Sound knowledge of the clinical trial processes and procedures including regulatory standards.
- Proven track record in working within clinical research in the pharmaceutical, CRO or NHS environment.
- A good understanding of ICH-GCP and regulatory requirements.
- Experience in maintaining Trial Master Files/Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).
For more information or to apply for this position, please contact Amy Lloyd on 01438 842979 or via email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46758 in all correspondence.