SCOPE International AG
CTA (Clinical Trials Assistant)

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Company Description
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 studies in 30 countries, enrolling more than 86,000 patients worldwide. Scope International provides effective, high quality, flexible CRO services to the biotech, pharmaceutical, and medical device industries and we value each and every member of our important teams.
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 sponsors. 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 part-time, 4 days per week, with hybrid working arrangements. This is an excellent opportunity to gain valuable experience, skills, and knowledge in the exciting field of clinical research, with opportunities to develop into the highly sought-after CRA role. We are excited to hear from you!
Application Process
Apply via email to madamson@scope-international.com, including your CV and a short introduction (max 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.
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Skills, Qualifications and Experience
- Strong working knowledge of Microsoft 365, particularly Excel - essential
- Keen interest in a career in clinical research - essential
- Strong attention to detail - essential
- Strong organisational and time management skills - essential
- Effective problem solving skills - essential
- Ability to work independently and as part of a team - essential
- Strong work ethic - essential
- Experience of project tracking - preferred
- 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
- Knowledge of ICH GCP and clinical trials process - preferred, but training will be given
Job Description
- Supports the CRA with project specific day-to-day in-house tasks.
- Collects and prepares project specific documents.
- Translates selected essential documents upon request.
- 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.
- Supports the preparation of clinical trial agreements to be provided to clinical trial sites for negotiation.
- Supports essential document compliance review.
- Supports filing of trial documentation.
- Supports the set-up or preparation of documents for the investigator site files (ISF).
- Supports organisation of local investigator payments.
- Supports initial supply and re-supply of materials and trial medication for trial sites.
- Supports the CRA to inform the project management team about the local regular status, if applicable.
- Follows project specific procedures outlined in the monitoring plan.
- May be asked to attend project team meetings and to take meeting minutes.
- May act as an in-house point of contact for trial sites when the CRA is out on monitoring.
- Performs ongoing timely training on all necessary project-specific documents and information.
- Reports significant non-compliances immediately in accordance with company’s procedures if not otherwise defined in the project.
- Reports data breaches immediately in accordance with company’s procedures.
- Supports company’s risk management procedures.
- Supports the update and maintenance of SCOPE’s e-solutions.
- Completes company’s required expense reports in timely fashion and submit them with accurate supporting documentation (i.e. receipts and invoices).
- Adheres to company’s policies and travel guidelines.
- Adheres to company’s SOPs and working instructions, guidelines and legislation.
- Assumes roles outside the job description as reasonably required for the benefit of the employer, if in line with the qualification.
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