Clinical Study Coordinator
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 Study Coordinator - multiple opportunities - can be based at either of our sites in Stirling or Motherwell and will involve travel to clinic sites across Scotland
Permanent / Full-time
As a Clinical Study Coordinator, you will provide support to the Clinical team under the direction of senior team members and assist with trial administrative functions. This is an exciting and unique opportunity for an individual keen to progress to a highly skilled independent CRA after a successful training period.
As part of the development of our products, LumiraDx collects samples from patients under ethically approved protocols at multiple clinical sites in the UK. The clinical team are responsible for the design, approval, implementation and management of these studies.
As a Clinical Study Coordinator you will be responsible for preparing, reviewing and archiving clinical study documentation. You will also monitor and train clinical study sites on the LumiraDx platform. In addition, you will be responsible for ensuring that clinical samples shipped from multiple clinical sites and vendors are processed, tested and stored as per LumiraDx internal policies and procedures.
- Clinical lead for ordering, preparing and distributing clinical study supplies.
- Manage the meter and strip supply to the clinical sites throughout the life-cycle of the study.
- Co-ordinate patient timetables with the clinical sites and liaise with R&D Technical Managers with regards to LumiraDx staffing requirements at clinical sites.
- Co-ordinate monitoring and courier timetables.
- Conduct training, monitoring and close-out of clinical studies to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCP and ISO 20916.
- Support clinical colleagues in the preparation, filing and archiving of various clinical documentation from study set-up through to close out
- Comply with appropriate ICH GCP standards and relevant sections of the EU IVDD/IVDR, US Code of Federal Regulations Title 21 (21 CFR) and ISO 20916.
- Work with multiple internal and external stakeholders to ensure clinical studies are conducted to appropriate business and ethical standards.
- Review and update clinical procedures to meet regulatory and business needs.
- Assist with periodic review of study files for completeness to ensure that they are audit ready at all times.
- Manage effective clinical and/or supplier relationships.
- Understand the relevant clinical requirements from the various R&D project teams
- Excellent communication skills, especially written and verbal to ensure all key stakeholders are kept current and effective relationships (both internally and externally) are built.
We are looking for highly self-motivated individuals with exceptional attention to detail and high level skills in organisation along with the following experience:
- A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or equivalent experience
- Ability to contribute to the development of clinical trial related documents and materials
- Excellent communication skills, including the ability to present complex information to both clinical and non-clinical disciplines.
- Willingness and ability to travel
- Hold a driving license
For further information and to apply for this role, please click APPLY