Clinical Research Associate
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
Permanent / Full-time
Working as part of the Clinical team you will be responsible for conducting all clinical studies to support product development, regulatory submissions and post-market evaluation for In Vitro Diagnostic products developed for use with the LumiraDx Platform. Studies will range from single site to international multi-centre so some travel will be required. The role will implement, monitor and review studies in line with our business plan whilst meeting all ethical, regulatory and scientific needs.
- Implement clinical trial study design as per the product launch plan.
- In conjunction with the Clinical Manager and Senior CRA, identify appropriate clinical sites and manage effective clinical relationships. Liaise with the Principal Investigator and clinical operations staff as required.
- Attend investigator meetings as required.
- Prepare, edit, review and submit clinical documentation according to study needs including but not limited to:
- Ethics Submissions
- R&D Applications
- Protocols & Protocol Amendments
- Patient Information Sheets
- Consent Forms
- Training Materials
- Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g. IRAS, HRA, R&D.
- Implement, conduct, monitor and report clinical studies according to all business processes.
- Monitor clinical trials to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCP, typically 50% of active sites.
- Ensure CRF and source data verification compliance.
- Perform pre-study initiation, interim monitoring and close out visits as required.
- Provide continuous up-dates on trial status to relevant key stakeholders, identifying potential delays that may impact product launch.
- Train clinical users on the LumiraDx system and other relevant products.
- Comply with appropriate ICH GCP standards and relevant sections of the IVD Directive and US Code of Federal regulations, Title 21 (21 CFR).
- Work with multiple stakeholders to ensure clinical studies are conducted to appropriate business and ethical standards.
- Review and up-date clinical procedures to meet regulatory and business needs.
- Responsible for ensuring that clinical trial master files are "audit ready" at all times.
To be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You should ensure positive, productive and proactive relationships with a range of internal and external key stakeholders
- A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or equivalent experience or a minimum of one years’ experience in performing a Clinical Research Associate role preferably with Medical Devices or In Vitro Medical Devices.
- Work experience within either a Hospital, Medical/Research Centre environment, Contract Research Organisation or Pharmaceutical company.
- Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.
- Ability to contribute to the development of clinical trial related documents and materials.
- Ability to perform pre-study initiation, interim monitoring and close out visits as required.
- Excellent communication skills, including the ability to present complex information to both clinical and non-clinical disciplines.
- Computer literate.
- Receptive to working in a fast-paced, constantly changing work environment.
- Willingness and ability to travel.
- Driving licence.
- Knowledge of statistics.
- Knowledge of FDA regulatory requirements.
- Experience across a wide range of clinical indications/therapeutic areas.
For further information and to apply for this role, please click APPLY