Job Description

Due to the increasing workload a new trials co-ordinator position is being funded by Beacon Therapeutics, a biopharmaceutical company focusing on the development of therapies for retinal dystrophies, specifically, retinal gene therapy for Retinitis Pigmentosa, (RP,) a rare inherited cause of blindness that affects around 1 in 50,000 people.



The main role of the trial coordinator will be managing the gene therapy research portfolio of the Eye Research Group Oxford department. This involves coordinating assigned research studies with in-depth knowledge of specific trials, managing protocol documents and amendments, and collaborating with Sponsors, Investigators, and the Research Nursing Team. Key responsibilities include overseeing participant recruitment, visits, and queries to ensure compliance with protocols and regulations. The role also requires close communication with R&D Governance, finance departments, and external trial sites. It involves maintaining accurate paper and electronic documentation in the Trial Master File (TMF) for monitoring and audits. Additionally, the role supports the implementation of research studies following ICH-GCP guidelines, the Research Governance Framework, and all relevant regulatory legislation.



The main objective of this trial co-ordinator is to manage the gene therapy research portfolio of the Eye Research Group Oxford department, supporting the professional lead for the gene therapy programme. To ensure that comprehensive, high-quality and efficient administrative processes are in place for setting up gene therapy studies, processing the necessary approvals (REC, HRA, MHRA, R&D research networks etc.) in association with the sponsor/Clinical Research Organisation (CRO), ensuring full compliance with the regulatory framework, including having an input in the financial management of study set-up costs.



Support the implementation and delivery of research studies per The International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the Research Governance Framework and all regulatory legislation in their day-to-day practice.



The post-holder will work with the gene therapy cohort of Ophthalmology patients with the Principal Investigator, ensuring each gene therapy study is efficiently run, meeting all clinical, ethical and financial targets.



This list of responsibilities will develop over time and as knowledge and experience to the post is established. The proportion of time devoted to each task will vary from time to time, according to any time-sensitive activities for the specific gene therapy project and department.



Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.



Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.



We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.



These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel .



Please refer to the attached and Person Specification with details on the main responsibilities for the role.