Job summary
The Neuromuscular Trials Coordinator will be an autonomous practitioner working within the multi-disciplinary team. The post holder will be required to coordinate and support clinical trials within the CNMD, with focus on SORD-CMT and its treatment through aldose reducase inhibitor (Govorestat, Applied Therapeutics). Responsibilities include collating and managing regulatory documentation to ensure the team is conducting research in accordance with international and UK regulations, and local guidance. This post will involve, among other tasks: preparation of ethics, HRA, MHRA, and R&D (UCLH/UCL Joint Research Office) submissions, liaising with sponsors and clinical research facilities, preparing trial budgets, negotiating contracts, liaising with other staff, coordinating audits and inspections, dissemination of information about studies. The post holder will also be required to organise and coordinate trial patient visits and liaise with international sites and funders.
The post holder is also expected to deliver on a range of administrative and project support services to support the clinical investigator team, both in terms of clinical and translational research
The post holder will function as part of a dynamic team and have an active involvement in the wider NHNN and neuromuscular and research teams.
Main duties of the job
o The post holder will be working within a team of research nurses, study co-ordinators, clinicians and scientists within the CNMD.o The post holder will be based at Queen Square House - Institute of Neurologyo Play a major role in overseeing and conducting clinical trials as part of the NHNN and UCL neuromuscular disease clinical and research teams.o Prepare documents for ethics, HRA, MHRA, and R&D (UCLH/UCL Joint Research Office) submissions.o Liaise with sponsors and clinical research facilities, prepare trial budgets and negotiate contracts.o Liaise with other staff, coordinate audits and inspections, disseminate information about studies.o Monitor patients entering and participating in research.o Liaise with multidisciplinary teams to ensure the smooth set-up and conduct of the study in accordance with the protocols and relevant legislation and guidelines.o Maintain and update clinical study database(s) of patients for research.o Take responsibility for other duties relevant to the effective running of the trials, namely data entry, if required.o Deliver on a range of administrative tasks to support the clinical and translational teamo Maintain and ensure the smooth running of a highly dynamic translational research groupo Manage lab resources and budgets and assist with budgeting and financial overviews.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
National Hospital for Neurology and Neurosurgery
Royal National ENT and Eastman Dental Hospitals
University College Hospital Grafton Way Building
Royal London Hospital for Integrated Medicine
University College Hospital Macmillan Cancer Centre
The Hospital for Tropical Diseases
University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the third year in a row.
UCLH recognises the benefits of flexible working for staff To find out more, visit: Flexible working.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the third year in a row.
UCLH recognises the benefits of flexible working for staff To find out more, visit: Flexible working.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Person Specification
Knowledge and Qualifications
Essential
- First degree in scientific/healthcare related discipline or equivalent experience
Knowledge and Experience
Essential
- Experience of working in clinical trials settings.
- Experience of setting up commercial and non-commercial clinical trials, including budgets.
- Comprehensive understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials and the UK Policy Framework for Health and Social Care Research.
- Familiar with the regulatory processes in the UK required for authorising, conducting and terminating clinical research.
- Excellent working knowledge of EU pharmacovigilance requirements.
- Experience of working in a pharmaceutical company, contract research organisation, academic clinical trials unit or similar organisation.
- Experience of preparing regulatory and ethics submissions, writing/amending protocols, Participant Information Sheets, case report forms and other relevant trial management documentation.
- Experience of range of computerised software
- Understanding of medical terminology
Desirable
- Excellent working knowledge of Good Clinical Practice (GCP) and good knowledge and understanding of other related standards such as Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP).
- Demonstrable level of administrative experience at a high level of competence acquired through both training and experience
Skills and Abilities
Essential
- Excellent administrative and organisational skills.
- Ability to write in a scientific, concise, technical, and cohesive manner.
- Resourceful and able to act on own initiative,
- A willingness to undertake further training as necessary and relevant to mee the needs of the team.
- Flexible and supportive approach to team working, and a proactive approach to develop and document systems and procedures.
- Outstanding organisational skills, managing several projects that are often time pressured, concurrently.
- Ability to prioritise activities despite conflicting pressures.
- Ability to summarise scientific data/information.
- Ability to maintain adherence to written procedures.
- Keen to remain up to date with current and new research legislation and guidance and willing to undertake further training related to this as required.
- A willingness to undertake further training as necessary and relevant to meet the needs of the department/team.
- Demonstrable level of administrative experience at a high level of competence acquired through both training and experience
- Excellent It skills, Including Word, Excel, powerpoint, Access/ databases and internet/email.
- A willingness to undertake further training as necessary and relevant to mee the needs of the team.
Desirable
Personal and People Development
Essential
- Demonstrates a clear vision of the role and service.
- Able to work across organisational and professional boundaries.
- Able to work autonomously.
Desirable
- Understanding of relevant national strategy / policy and how this relates to research governance.
Responsibilities towards promoting Equality Diversity and Inclusion
Essential
- All posts to include Demonstratable understanding of the Equality, Diversity, and Inclusion and/or Knowledge of the NHS obligations under the Equality Act 2010 and the Public Sector Equality Duties (line managers to elaborate depending on the level of the post and to assess this essential criteria at interview)
Specific Requirements
Essential
- Understanding of appropriate health and safety legislation.
Desirable
- Awareness of budgetary management.
Person Specification
Knowledge and Qualifications
Essential
- First degree in scientific/healthcare related discipline or equivalent experience
Knowledge and Experience
Essential
- Experience of working in clinical trials settings.
- Experience of setting up commercial and non-commercial clinical trials, including budgets.
- Comprehensive understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials and the UK Policy Framework for Health and Social Care Research.
- Familiar with the regulatory processes in the UK required for authorising, conducting and terminating clinical research.
- Excellent working knowledge of EU pharmacovigilance requirements.
- Experience of working in a pharmaceutical company, contract research organisation, academic clinical trials unit or similar organisation.
- Experience of preparing regulatory and ethics submissions, writing/amending protocols, Participant Information Sheets, case report forms and other relevant trial management documentation.
- Experience of range of computerised software
- Understanding of medical terminology
Desirable
- Excellent working knowledge of Good Clinical Practice (GCP) and good knowledge and understanding of other related standards such as Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP).
- Demonstrable level of administrative experience at a high level of competence acquired through both training and experience
Skills and Abilities
Essential
- Excellent administrative and organisational skills.
- Ability to write in a scientific, concise, technical, and cohesive manner.
- Resourceful and able to act on own initiative,
- A willingness to undertake further training as necessary and relevant to mee the needs of the team.
- Flexible and supportive approach to team working, and a proactive approach to develop and document systems and procedures.
- Outstanding organisational skills, managing several projects that are often time pressured, concurrently.
- Ability to prioritise activities despite conflicting pressures.
- Ability to summarise scientific data/information.
- Ability to maintain adherence to written procedures.
- Keen to remain up to date with current and new research legislation and guidance and willing to undertake further training related to this as required.
- A willingness to undertake further training as necessary and relevant to meet the needs of the department/team.
- Demonstrable level of administrative experience at a high level of competence acquired through both training and experience
- Excellent It skills, Including Word, Excel, powerpoint, Access/ databases and internet/email.
- A willingness to undertake further training as necessary and relevant to mee the needs of the team.
Desirable
Personal and People Development
Essential
- Demonstrates a clear vision of the role and service.
- Able to work across organisational and professional boundaries.
- Able to work autonomously.
Desirable
- Understanding of relevant national strategy / policy and how this relates to research governance.
Responsibilities towards promoting Equality Diversity and Inclusion
Essential
- All posts to include Demonstratable understanding of the Equality, Diversity, and Inclusion and/or Knowledge of the NHS obligations under the Equality Act 2010 and the Public Sector Equality Duties (line managers to elaborate depending on the level of the post and to assess this essential criteria at interview)
Specific Requirements
Essential
- Understanding of appropriate health and safety legislation.
Desirable
- Awareness of budgetary management.
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
University College London Hospitals NHS Foundation Trust
Address
National Hospital for Neurology & Neurosurgery, UCLH
Queen Square
London
WC1N 3BG
Employer's website
https://www.uclh.nhs.uk (Opens in a new tab)
