Clinical Trial Technician
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Clinical Trial Technician - multiple opportunities - these roles will be based at our site in Manchester but will require travel to clinical sites.
Permanent / Full-time
As a Clinical Trial Technician you will be responsible for reviewing, processing, testing and storing clinical samples within LumiraDx and also clinical samples shipped from multiple clinical sites and vendors. You will also be responsible for in-putting clinical information associated with clinical samples into a database and ensuring, safe storage and control. This role will be based at our site in Manchester. The clinical sites are currently based in various hospitals and laboratories throughout the UK.
- Receive, process, test, aliquot and store clinical samples
- Input clinical information into the LumiraDx Sample Management System
- Perform testing of clinical samples on clinical analyser reference systems on site
- Carry out routine verification, calibration, maintenance and operation of laboratory equipment and clinical analysers
- Order, prepare and distribute clinical trial supplies
- Support the clinical team in the following areas:
- Up-date and maintain clinical systems.
- Prepare, handle, distribute, file and archive clinical documentation.
- Review Clinical Trial Master Files both paper and electronic ensuring compliance.
- Adhere to all relevant GLP and GCP procedures.
- Work in conjunction with the quality policy and objectives.
- Ensure that all clinical samples are fully traceable and studies are "audit ready" at all times.
- Initiate and investigate non-conformances and ensure closure to agreed timelines.
- Draft new processes/procedures as required.
- Understand the relevant clinical requirements from the various R&D project teams.
- Excellent communication skills, especially written and verbal to ensure all stakeholders are kept current and effective relationships (both internally and externally) are built.
- Be solution focused and work as part of a multidisciplinary team to proactively meet and balance the business objectives and clinical requirements.
- Train others in areas of expertise and ensure personal training is up to date.
- Work effectively within the clinical team and R&D project teams.
We are looking for highly self-motivated individuals with exceptional attention to detail and high level skills in organisation along with the following experience:
- Experience of working with clinical samples and track record of working within GLP and/or GCP guidelines
- Experience of working in or with the NHS
- Laboratory technician experience of using a wide range of commercial diagnostic clinical analysers
- Confidence working without supervision in a laboratory and/or clinical environment
- Computer literacy
- Attention to detail and high level of organisational skills
- Good numeracy skills
- Must be able and willing to travel to clinical sites, using own transport
- Receptive to working in a fast-paced, constantly changing work environment
- Current driving licence, with your own transport
For further information and to apply for this role, please click APPLY