Description
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
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