Our client is a small pharmaceutical company based in central London. They are seeking a Clinical Trial Assistant to join their team on a permanent basis. This CTA position will have the opportunity for you to develop into a CRA or Study Manager.
- The Clinical Trial Assistant will assist clinical trial operations, with in-house activities associated with the management of assigned clinical projects and will have the responsibility for all administrative activities including communication, file management, tracking databases and supply inventory activities.
- The trials assigned may be either sponsored by the company or conducted on behalf of its partners.
- The position will work within the Head of Clinical Operations group and will report into an assigned Senior Clinical Project Manager
- Provide administrative support for projects
- Create, update, track, and maintain project-specific trial management files, tools, and systems.
- Ensure project and study files (Trial Master File (TMF)) are set up maintained and audit ready at all times, both on paper and electronically. This involves filing of documents and regular QC checks.
- Assist publishing and administrative QC of all project-specific documents (e.g. protocols, investigator brochure, and regulatory submissions) in a timely manner.
- Track regulatory and ethics submissions, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools.
- Assist with the management and tracking of study non-clinical supplies to sites and organize shipments.
- Assist with management and tracking of study clinical supply.
- Co-ordinate meetings with clients, investigators and internal teams. This includes scheduling, sending invitations, preparation of agenda, materials and presentations and taking accurate and complete minutes.
- Act as a contact for project team and study sites.
- Take responsibility for various project administrative activities, as required.
- Create, update and maintain clinical department management tools and systems, as required.
Education and Experience:
- Minimum of two (2) years' administrative experience in a corporate environment or preferably, minimum of two (2) years Clinical Project Administrator experience.
- Computer literacy (including relevant software, such as Excel, Word, PowerPoint, Adobe plus specific regulatory packages).
- Familiarity with Clinical Trial documents,
- Basic knowledge of ICH-GCP and relevant regulations.
- Excellent oral and written communication skills.
- Enjoys working in a regulated environment and willing to comply with CT Catapult Standard Operating Procedures and Policies
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Good spelling and proofreading skills.
- Must be flexible to cross over London between sites in London and Stevenage
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.