Clinical Research Associate

4 weeks ago

London, United Kingdom Odin Vision Full time

**Clinical Research Associate - UK/Europe/Hybrid**

We are looking for an experienced Clinical Research Associate to support the clinical assessment of Odin Vision's Medical Devices, in a full-time role. The job will involve collecting and analysing data to assess the useability and performance of Odin's software as a medical device (SMD), in clinical practices across Europe. The progress of these assessments will need to be communicated and reported to key staff members. The role will also involve providing support to hospital staff to facilitate the integration of the device into their clinical workflow.

This job is a full-time hybrid role, with the requirements to travel internationally.

**Salary range - £35-50K**

**What you'll do**:

- Develop procedures and methodology for the collection and analysis of case study data assessing the useability and performance of a software as a medical device (SMD).
- Conduct case studies and analyse quantitative and qualitative data.
- Present findings internally and write final reports.
- Assist with the integration of an SMD into clinical practice and ensure the device functions as intended.
- Gather and report clinician feedback.
- Verify that clinical data collection is conducted according to good clinical practice (GCP), standard operating procedures (SOPs) and other compliance standard.
- Develop and amend protocols, patient and clinician facing documentation, electronic databases, and other trial management documentation.
- Plan and execute the collection of clinical evidence for regulatory approval and post-market follow up.
- Support training of hospital staff members and research staff for the execution of clinical trials.
- Perform monitoring visits.
- Contribute to the development of end of trial reports for regulatory approval.

**Qualifications**
- An undergraduate degree, or equivalent in a biomedical or scientific field.
- Good Clinical Practice Certification

**Required experience**:

- Conducting clinical research in an academic or clinical environment.
- Contributing to the development of study designs and the writing of study protocols.
- Data analysis.
- Writing study reports or research papers.

**Desirable for the role**:

- Primary authorship of study protocols and end of study reports (e.g. Clinical Investigation Reports).
- Quantitative and qualitative data collection and analysis.
- Comprehensive knowledge of clinical workflows in Endoscopy.
- Working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act, GDPR and Research Governance Framework legislation.
- Proven clinical research experience with Medical Devices.

At Odin Vision we believe that diversity is an important contributor to our success and long-term company goals. Diversity in our teams can contribute to innovations and creativity and increase our ability to cope with change. Odin Vision is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

**Clinical Research Associate - UK/Europe/Hybrid**

**Find out more**:
Follow Odin Vision on LinkedIn

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