About us
Scope International are a full service CRO (Clinical Research Organisation). Our head office is based in Mannheim, Germany and we have a wide network of offices across Europe and the UK. We are proud to have supported over 300 clinical trials, and over 85,000 patients worldwide. Scope International provide effective, high quality, flexible CRO services to the biotech, pharmaceutical and medical device industries and we appreciate each and every member of our important teams. You can find more about us here
Role Description
This is a 12 month, fixed term post in the first instance, with possibility of extension. The clinical trials administrator / assistant role is an integral part of our UK team and is required to support our CRA team, and wider team across a range of clinical trials. There will be opportunity to work across a range of therapeutic areas and Sponsor's. We are looking for a special candidate, with a 'can-do' attitude, who is flexible and a real team player, whilst also being comfortable working autonomously. The role is full time, with hybrid working arrangements of 3 days working from our Bolton office, and two days working from home. This is an excellent opportunity to gain further experience, skills and knowledge in the exciting field of clinical research and we are excited to hear from you!
Application Process
Apply via email to lmurray@scope-international.com, including your CV and a short introduction (no more than 500 words) to explain why you would like to be considered for the role, and why you would be a good fit for our team.
Interview date
Tuesday 4th March
Start date
March / April 2025
Deadline for applications to be received
Midnight on 27th February 2025
Terms
Fixed term 12 month post in the first instance, with possibility for extension.
Skills, Qualifications, Experience
* Effective communication skills - essential
* Strong working knowledge of Microsoft office packages, particularly Excel and Word - essential
* Experience of project tracking - preferred
* Strong attention to detail -essential
* Knowledge of clinical trials process - preferred
* Strong organisational and time management skills - essential
* Effective problem solving skills - essential
* Ability to work independently and as part of a team - essential
* Previous experience in a CTA or similar role - preferred, but the right fit for our team is more important!
* Bachelor's degree in a relevant field, such as life sciences or healthcare - preferred
* Strong work ethic - essential
* Ability to be flexible - essential
* Keen interest in a career in clinical research - preferred
* Knowledge of ICH GCP - preferred, but training will be given
Job Description
1. Supports the CRA with project specific day-to-day in-house tasks.
2. Collects and prepares project specific documents.
3. Translates selected essential documents upon request.
4. Supports collection and review of documents for regulatory submission. If applicable due to national regulations supports submission of document to relevant CAs and EC/IRBs.
5. Supports the preparation of clinical trial agreements to be provided to clinical trial sites for negotiation.
6. Supports essential document compliance review.
7. Supports filing of trial documentation.
8. Supports the set-up or preparation of documents for the investigator site files (ISF).
9. Supports organisation of local investigator payments.
10.Supports initial supply and re-supply of materials and trial medication for trial sites.
11. Supports the CRA to inform the project management team about the local regular status, if applicable.
12. Follows project specific procedures outlined in the monitoring plan.
13. May be asked to attend project team meetings and to take meeting minutes.
14. May act as an in-house point of contact for trial sites when the CRA is out on monitoring.
15. Performs ongoing timely training on all necessary project-specific documents and information.
16.Reports significant non-compliances immediately in accordance with company’s procedures if not otherwise defined in the project.
17. Reports data breaches immediately in accordance with company’s procedures.
18. Supports company’s risk management procedures.
19. Supports the update and maintenance of SCOPE’s e-solutions.
20. Completes company’s required expense reports in timely fashion and submit them with accurate supporting documentation (i.e. receipts and invoices).
21. Adheres to company’s policies and travel guidelines.
22. Adheres to company’s SOPs and working instructions, guidelines and legislation.
23 .Assumes roles outside the job description as reasonably required for the benefit of the employer, if in line with the qualification.