Clinical Trials Coordinator

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Clinical Trials Coordinator (CTC) to join our team.
The CTC is an external facing role. CTCs coordinate all Clinical Trial activities from set up of the documentation and initiation of the sites to site close out. CTCs are responsible for ensuring that clinical sites have all the documentation, equipment and support they need to conduct out the study. This will involve some national and international travel, sometimes at short notice.
You will need the ability to coordinate and lead site interactions for multiple clinical studies of a limited complexity or provide support to a Senior CTC or Clinical Trials Project Manager for more complex trials. You will need superb communication and organisational skills as you will be supporting several studies simultaneously.
Working in collaboration with the other members of Clinical Study Delivery and with a wide range of internal and external customers, this role is pivotal to the success of Owlstone.
Key tasks & Accountabilities
You will be responsible for all the documentation, equipment and site set up for your assigned clinical trials including those tasks typically carried out by a CTA. You will also work with Senior members of the team to support site set up for more complex trials such as CTIMPs:

- Responsible for preparation of study documents
- Assist SCTC/PM in performing submissions to EC and regulatory bodies
- You will be responsible for ensuring the right equipment is available and shipped to the site, conduct of a project kick off meeting and providing documentation and training on breath sample collection
- Oversee study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues
- You will ensure that all decisions are documented and that all records are accurate and kept according to the appropriate SOPs and provide stakeholder reports as required
- Ensure documentation is stored appropriately in the document management system
- 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
- Provide guidance for Clinical Trials Administrator (CTA) to set up the Trial Master File. Ensure all documentation complete and present in the TMF, through regular updates and checks throughout the study
- 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
- You will ensure that returned samples are handled according to OML protocols and either passed to the lab for immediate processing or stored correctly.
- Ensure end-to-end testing on the software to be used for sample collection
- Work closely with the Clinical Data Manager, CTS and PM to build and test the eCRF (e.g OpenClinica)
- Responsible for ensuring sites are closed out appropriately and all equipment returned promptly
- Be responsible for training more junior staff and provide induction training for new starters
- Responsible for peer review of completed documentation and QC check of documentation preparation by CTA for delivery to external sites and customers
- Monitor recruitment at sites and report on status and deviations from expectations
- Visit clinical sites for the purpose of training, monitoring and understanding recruitment issues

**Requirements**:
**Essential**:

- Experience as a CTA or similar role within clinical study delivery
- Experience of maintaining TMF
- Excellent written and verbal communication skills and be comfortable interacting with a wide range of people.
- Further education in a technical or science discipline or equivalent experience
- Experience of Good Clinical Practice
- Competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA and Confluence, etc.

Desirable
- Experience working with CTIMPs
- Experience in a similar CTC role
- 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
- Experience of setting up CRFs and performing site feasibility and initiation

**Benefits**:
About Owlstone Medical
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 high