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Senior Clinical Trials Coordinator

  • Closing date 31 Aug 2022
  • Type Full-time
  • Duration Permanent

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and conduct a number of clinical studies to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Senior Clinical Trials Coordinator to join our team.

To fulfil our mission to save lives, we conduct a range of clinical studies, including observational trials, first in human trials, proof of concept studies and later stage trials as required in order to support breath biomarker discovery, development and safety assessment of novel probes of metabolism and medical device development and approval. This diversity means that every study has its own unique challenges to overcome.

The Senior CTC is an external facing role, co-ordinating all clinical activities from start-up until close-out, and ensures that all clinical sites, have the approval and documentation required and receive the support they need to carry out the study in compliance with the protocol and expected timelines.

 

Key tasks & Accountabilities

You will be expected be able to manage and drive the full life cycle of the clinical study.

You will have the skills and drive required to step in and ensure that anything related to the implementation and conduct, that comes up during the course of the clinical study is actioned and addressed appropriately and in a timely manner.

You will be responsible for the following:

  • Study set up
  • Preparation of study documents
  • Preparation, review and submission to Ethics Committees and Regulatory Authority submission packages as required
  • Securing approval of submissions from Ethical Committees
  • Ensuring the right equipment is available, tested appropriately and shipped to the site
  • Conduct of a project kick off meeting
  • Providing training and documentation on breath sample collection
  • Ensuring that the appropriate insurances are in place
  • Provide input into contracts / schedule of work / service agreements
  • Work with the Clinical Data Manager, CTS and PM to build and test the eCRF
  • Ensure completion of site feasibility questionnaires by proposed clinical sites
  • Study Conduct
  • Visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required and for the purpose of training, monitoring and understand barriers to recruitment
  • Monitor and critically review the performance of different sites and feedback on this to the appropriate stakeholders and document any deviations to protocol or delivery timelines
  • Oversee study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues
  • Lead internal R&D support by setting up equipment and systems appropriately, recruiting volunteers, obtaining informed consent and collecting breath samples
  • Interface with Manufacturing and the Breath Biopsy Lab (BBL) to ensure consumable requirements are understood and accounted for during the lifecycle of the study
  • Ensure that returned samples are handled according to OML protocols and either passed to the lab for immediate processing or stored correctly.
  • Study Close out
  • Responsible for ensuring sites are closed out appropriately and all equipment returned promptly
  • Training / and other study support
  • Provide training and guidance for new and junior members of the team on all aspects of clinical study delivery.
  • Ensure all documentation complete and present in the TMF, through regular updates and checks throughout the study
  • Responsible for QC check and peer review of all documentation for delivery to external sites ad 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
  • Identify improvements, prepare and perform reviews of departmental SOPs, templates and forms
  • Ensure that non-conformances are logged, CAPA investigations performed and improvements implemented
  • In addition you should be able to:
  • Deputise, from time to time, for more senior project managers
  • Input estimated timelines and requirements for current and future studies into appropriate forecasting sheets
  • Ensure that the received samples and resultant data are processed as scheduled, and that all internal issues are resolved to the customers satisfaction
  • Ensure that the final output meets the customers’ expectations.
  • Ensure the study is formally closed out, including lessons learned and client feedback where possible

 

Requirements
Essential

  • Experience as a CTC or similar role within clinical study delivery
  • Experience of ethical or regulatory authority submissions, maintaining TMFs and set up of CRFs
  • Further education in a technical or science discipline or equivalent experience
  • Excellent knowledge of Good Clinical Practice
  • Experienced trainer with confidence to train others in off-site settings
  • Excellent written and verbal communication skills and be comfortable interacting with a wide range of people

Desirable

  • A good awareness of the regulatory issues and requirements surrounding clinical trials and research studies
  • Experience in a similar Senior CTC role
  • Line management, team leadership, coaching or mentoring experience
  • Experience of working with CTIMPs and ISO 9001 Quality Management System
  • Experience co-ordinating clinical trials performed in NHS sites and with clinical trials supporting medical devices approval


About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) 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.

Benefits

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 careers@owlstone.co.uk.

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