Clinical Study Delivery Coordinator

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, within Clinical Study Delivery we support a number external customer clinical projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Study Delivery Coordinator to join our team.

This is an external facing role, supporting and co-ordinating all study activities from set up of the documentation, initiation and training of the sites, monitoring of sample collection, through to supporting the internal analysis of samples, closing sites and reporting back on the findings.

This role will require international travel to support training of sites on our technology. When not travelling, this role is onsite at our Cambridge offices.

Key Tasks and Accountabilities

You will be responsible for all the documentation, equipment and site set up for your assigned studies including those tasks typically carried out by other members of the Customer Study Delivery team.

You will be responsible for the following:

• Customer and site communications from study set up until close out
• Ensuring quality of sample collection, receipt and data
• Accurate tracking and reporting of costs and timelines
• Preparation, management and review of study documentation

Study set up

• • Ensuring the right equipment is available, tested appropriately and shipped to the site
  • Conduct of a project kick off meeting with internal and external customers
  • Providing training (in person at clinical sites) and documentation on breath sample collection
  • Input into study contracts and review of clinical protocols

Study conduct

• • Lead study review meetings to discuss recruitment and study design with internal and external customers
  • Visit clinical sites to review the accuracy of sample collection and provide additional training and support as required
  • Monitor recruitment at sites and report on status and deviations from expectations
  • Check sample quality and request repeats where required
  • Study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues
  • Interface with internal teams to ensure consumable requirements are understood and accounted for during the lifecycle of the study

Study Close out

• • Responsible for ensuring sites are closed out appropriately and all equipment returned promptly
  • Support data analysis and interpretation with input based on customer expectations and sample collection / recruitment knowledge

Training and other study support

• • Be responsible for training more junior staff and provide induction training for new starters
  • Provide guidance on management of documentation
  • Responsible for peer review of completed documentation and QC check of documentation for delivery to external sites and customers

Quality Management

• • Ensure that all decisions are documented and that all records and documentation are accurate and stored appropriately according to the appropriate SOPs and provide stakeholder reports as required
  • Raise and log non-conformances and contribute to CAPA investigations and implementation of improvements
  • Highlight gaps and contribute to updates and reviews of departmental SOPs

Requirements

Essential requirements

• Experience in Clinical Study Delivery
• Experience in working with customers and / or clinical sites
• Experience of maintaining study documentation
• Further education in a technical or science discipline or equivalent experience
• Experience of Good Clinical Practice
• Excellent written and verbal communication skills and be comfortable interacting with a wide range of people.
• Confident in using Microsoft Office tools

Desirable requirements

• Experience of setting up and training clinical sites
• Prior experience of coordinating clinical trials in Africa
• A good awareness of the regulatory issues and requirements surrounding clinical trials and research studies
• Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment

Benefits

About Owlstone Medical

Owlstone Medical is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using

Owlstone is an equal opportunity employer, and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and the attainment of a Baseline Personnel Security Standard (BPSS) check. Access to selected project information requires prior additional security authorization. Access to US technical data by employees requires prior Export Control function approval. Full clearance must be satisfactorily attained against all applicable project security and US export control authorisations. Failure to meet any reference, BPSS, project-security or export-control authorisations may have an impact on successfully completing your probationary period.

Notice to agencies

Owlstone Medical Ltd politely requests no contact from recruitment agencies or media sales. We don’t accept speculative CVs from recruitment agencies nor accept the fees associated with them. Should your agency wish to be considered in our next PSL review please contact careers@owlstone.co.uk