Job summary
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.
Main duties of the job
-
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.
About us
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.
Job description
Job responsibilities
Please refer to the attached Job Description and Person Specification with details on the main responsibilities for the role.
Job description
Job responsibilities
Please refer to the attached Job Description and Person Specification with details on the main responsibilities for the role.
Person Specification
Qualifications
Essential
- Diploma (minimum) / Degree or equivalent in relevant subjects
- ICH GCP Certified
Desirable
- Postgraduate qualifications
Experience
Essential
- 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
Desirable
- 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
Personal Skills
Essential
- 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
Desirable
- Knowledge of interventions and assessments involved in experimental medical research or willingness to undergo training in these areas
Technical skills
Essential
- Excellent IT skills and aptitude essential with a demonstrable ability and desire to utilise standard programmes such as Excel, Word or Access to a level appropriate for the requirements of clinical research conducted on an IT-based system.
Desirable
- Experience with data management systems / Clinical Research IT systems
Person Specification
Qualifications
Essential
- Diploma (minimum) / Degree or equivalent in relevant subjects
- ICH GCP Certified
Desirable
- Postgraduate qualifications
Experience
Essential
- 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
Desirable
- 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
Personal Skills
Essential
- 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
Desirable
- Knowledge of interventions and assessments involved in experimental medical research or willingness to undergo training in these areas
Technical skills
Essential
- Excellent IT skills and aptitude essential with a demonstrable ability and desire to utilise standard programmes such as Excel, Word or Access to a level appropriate for the requirements of clinical research conducted on an IT-based system.
Desirable
- Experience with data management systems / Clinical Research IT systems
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Oxford University Hospitals NHS Foundation Trust
Address
Eye Research Group Oxford
Oxford Eye Hospital, West Wing, LG1, John Radcliffe Hospital, Headley Way
Headington, Oxford
OX3 9DU
Employer's website
https://www.ouh.nhs.uk/ (Opens in a new tab)
