Clinical Trial Coordinator

3 weeks ago

Cambridge, United Kingdom Owlstone Medical Full time

The CTC may work across multiple studies and will co-ordinate all Clinical Trial activities from set up of study documentation, initiation of sites to site close out. CTCs are responsible for ensuring that clinical studies have all the documentation, equipment and support they need to conduct the study. The CTC will also take part in recruiting, consenting and obtaining breath samples for internal studies.

**Responsibilities/workload may include**:
Study set up
- Assist with the preparation of study documents
- Assistance in preparation of submissions and submission packages to EC and regulatory bodies
- Ensuring the right equipment is available, tested appropriately and shipped to the site
- Contribute and attend project set up and kick off meetings.
- Providing training (remotely or in person at clinical sites) and documentation on breath sample collection
- Work closely with the Senior CTC and Clinical Data Manager, to build, test and train sites on use of, the eCRF (e.g OpenClinica)

Study conduct
- Lead internal R&D support by setting up equipment and systems appropriately, recruiting volunteers, obtaining informed consent and collecting breath samples
- Monitor recruitment at sites and report on status and deviations from expectations
- Check breath 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 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.

Study Close out
- Responsible for ensuring sites are closed out appropriately and all equipment returned promptly

Training and other study support
- Be responsible for training more junior staff and provide induction training for new starters
- 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
- Responsible for peer review of completed documentation and QC check of documentation preparation by CTA 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**:

- Willing to recruit, consent and take breath samples for internal studies
- Experience as a CTA or similar role within clinical trials
- 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
- Confident in using Microsoft Office tools

**Benefits**:
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.

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