Clinical Research Associate
San Diego, US
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
The key objective of this role is to support product development, clinical trials, and post market clinical activities. The Job Holder will assist in the scientific management of US studies and clinical trials and will help support business objectives (as directed by the Global Clinicals Team). The Job Holder has responsibility for the timely delivery of quality US clinical trial data to support product development, regulatory submissions and post market evaluation of the LumiraDx products while meeting all ethical, and regulatory requirements. The Job Holder will manage the activities of our CRO(s), with the intention of building US Clinical trials capability in the longer term. The US Clinical Trials Manager reports directly to the VP of Scientific and Clinical Affairs (US) and is also accountable to the Head of Clinical & Medical Affairs (global programme).
- Ability to prepare, present, and negotiate clinical strategies with FDA as needed and with assistance from Scientific and Medical Affairs departments.
- Ability to work with CROs as required.
- Liaison with LumiraDx Global Clinicals programme to ensure US activities are fully aligned with overall LumiraDx strategy, delivery plan and timings for the LumiraDx platform and products.
- Building strong links and relationships with KOLs and clinical researchers to enhance LumiraDx’s position and access to potential US clinical trial sites.
- Assist in the implementation of internal procedures for clinical trial management in the US aligned with global Clinical and Quality Management system. This includes creation and maintenance of all clinical trial files, and file templates, including the trial master file, and oversight of all clinical site/CRO files. This must be compliant with FDA & IVDR procedures, LumiraDx Quality management procedures and any local regulatory, quality or clinical requirements.
- Selection and qualification of US clinical trial sites and Chief/ Principal investigators (PI).
- Selection, qualification, and management of CROs as required.
- In cooperation with US Scientific Affairs and Global Medical Affairs, develop clinical trial protocols and guidance of those protocols through the ethical approval process.
- Set up and deliver site initiation visits at the clinical trial sites, including training on patient recruitment, proper sample collection, documentation, data generation and reporting.
- Make regular monitoring visits to clinical trial sites and clinical investigators/PIs. Issue supplies, such as case report forms and investigational product (IUO). Regularly evaluate the quality of case reports and collaborate with clinical trial investigators/PIs to write final technical reports in a timely manner.
- Work with PIs to achieve adequate recruitment and timely delivery of quality clinical trial data, with continuous attention to recruitment rates and strategies to meet company deadlines.
- Ongoing remote and onsite monitoring of clinical trial progress to ensure compliance and adherence to the established protocol and to identify, evaluate and rectify problems in real-time.
- Coordinate and assist with the preparation and internal publication of study and clinical trial data, reports and information, ensuring that the data presentation meet legislative, contractual and ethical requirements.
- Work as team member of the Global Clinical Team, participating in regular meetings, presenting progress updates, and ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
- Support Medical Affairs in Post launch studies as requested.
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
- BS/BA or PhD Degree in biomedical, life science or healthcare field or clinical qualification such as MD.
- Previous experience as a CRA / Senior CRA / other significant experience and training in clinical trial research.
- Significant international clinical trials experience in the medical device industry (IVD is preferred).
- Direct experience within a Clinical Trials teams.
- Ability to work effectively on multiple projects in varying global locations simultaneously.
- Excellent written and verbal communication skills.
- Adaptable and able to work in an environment where priorities are constantly changing
- Ability to deliver the entire product pipeline from development clinics to full regulatory approval.
- Experience of CE marking and FDA studies for IVD
- Proficient with Microsoft Office Word, Excel, and bio-statistics.
- Ability to work independently and effectively prioritize responsibilities.
- Possess a valid US driver’s license.
- Possess a valid passport and be available for independent domestic and international travel as directed.
- Experience of managing regulatory trials for point of care tests or self-testing diagnostics for CE marking and FDA clearance.
- Established clinical network in the US.
For further information and to apply for this role, please click APPLY