Clinical Trials Coordinator

2 weeks ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

We are looking for a highly motivated and dynamic individual to facilitate the set up and smooth running of clinical trials in the Pharmacy Manufacturing Unit (PMU) at Guy's Hospital.

To be the primary contact for the management of clinical trial manufacturing within the PMU and to liaise with external research partners in the set up of new trials. The role will also involve management of trial stock including reconciliation, order processing and distribution to trial sites within the UK.

The PMU is a MHRA licensed unit holding a MIA(IMP) & MS License, handling a wide range of dosage forms including non-sterile oral liquids & suspensions, tablets, capsules, creams & ointments and terminally sterilised parenteral solutions, topical gels and eye drops. The PMU provides clinical trial manufacturing activities through our collaboration with Kings Health Partners and other clinical trial organisations.

The department is well resourced and comprised of over 50 production, quality assurance and quality control staff.

You will join the Production team and undertake the following key roles:

- Be responsible for the day-to-day running of the pharmacy clinical trials service, including but not limited to: - Stock management of clinical trial drugs and raw materials and finished products,
- Environmental monitoring of manufacturing and storage areas,
- Set up of pharmacy trial files and maintenance of existing files,
- Authoring of documentation and label design,
- Training of staff,
- Batch planning for upcoming studies and roll-out of new studies,
- Liaising with research teams, sponsors and sponsor representatives throughout the duration of a trial.
- Be responsible for ensuring the requirements of the production area’s quality management system are maintained and developed as required by the MIA(IMP) or MS licence (as required for clinical trials or physiological studies respectively) and NHS guidance.
- Support productivity initiatives and play a key role in improving the department’s key performance indicators.

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