Clinical Research Associate

LumiraDx is a global company with headquarters in the US and UK. We are a dynamic diagnostics company with over 1,000 employees developing breakthrough medical devices and connectivity solutions. We are committed to advancing health care through innovative diagnostic products and connected care solutions. The company is significantly expanding as it prepares to launch an innovative, next generation diagnostic platform, and is looking for a dynamic, experienced Clinical Trials Associate to support all US clinical trials.

Opportunity

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.

Key Areas of Responsibility

• 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
  • CRFs
  • 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.
  

About You

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

Essential skills

• A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or equivalent experience or a previous 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.

Desirable skills

• Knowledge of statistics.
• Knowledge of FDA regulatory requirements.
• Experience across a wide range of clinical indications/therapeutic areas.

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business

Please note, if you wish to submit an application for this role, please consider the following information:

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.