Temporary Clinical Trials Administrator
Looking for opportunities to expand your experience as an Associate Clinical Trials Administrator? Looking to work on a wide range of engaging and challenging projects? If so, we’d love to hear from you.
Aptus Clinical supports life science companies and academia in their quest to identify and develop valuable new medicines. We have a passion for drug development and a belief in the power of collective knowledge and collaboration.
This is a fantastic opportunity to join us as an Associate and work as a Clinical Trials Administrator.
Based in an open plan office, we foster an informal and fun, yet fast-paced environment. We believe that by bringing talented people together, we can deliver ground-breaking innovations to the world of medicine.
As a leading business, we are conscious of our social responsibility, and are committed to supporting pioneering drug development and prosperity in our region.
As the Clinical Trials Administrator you will be based at our offices and will provide the administrative support to the clinical development/project teams and maintaining a range of clinical documentation in line with ICH-GCP regulations.
Our projects will vary, but typically your responsibilities will include:
- Support the clinical trial activities on behalf of Aptus Clinical 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)
- 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
- Assists 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.
To be considered, you will need:
- A 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 and or 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
- 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
In return, we are able to offer competitive daily rates the chance for you to share your knowledge, challenge yourself and work with a diverse customer base on a wide range of projects.
To apply, please attach your CV and quote job reference JMC/CTA.