Gene Therapy Clinical Trial Coordinator Person Specification

Overview

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.
• The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

• Diploma (minimum) / Degree or equivalent in relevant subjects
• ICH GCP Certified

• Postgraduate qualifications, Relevant experience in managing and supervising research and other staff
• Proven experience of clinical trials set up / coordination involving an IMP with data management
• Experience in the management of Phase I, II and III clinical research studies conducted to ICH GCP standards
• Experience in maintaining well-documented training records
• Personal involvement in the generation of ethical or regulatory submissions for clinical study protocols
• Experience in working in a hospital setting
• Have an understanding of financial expenses and sourcing finance for the management of the team, Able to prioritise and work competently under your initiative within the boundaries of the role
• Ability to work with a high level of attention to detail
• Thorough understanding of the modern requirements of Good Research Governance and the rights of individuals participating in clinical research protocols
• Able to discuss complex information e.g. about study designs, clinical interventions, research equipment or operation with other professional groups
• Able to exercise own initiative when dealing with common issues within own specialist area of competence
• Able to coordinate multiple research projects
• Knowledge of interventions and assessments involved in experimental medical research or willingness to undergo training in these areas

• Ess…