Job summary
The NIHR UCLH Clinical Research Facility is a well-established Clinical Research Facility covering two sites; a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at 170 Tottenham Court Road, and the Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square.We are looking to recruit a self-motivated and enthusiastic Clinical Trials Coordinator (CTC) to work in the CRF and be responsible for leading on the set-up and implementation of commercial clinical trials, liaising with study teams, service departments, study sponsors, the NIHR CRN: North Thames and the Joint Research Office (JRO) to ensure trials are set up in a timely manner and run efficiently at the CRF. The post holder will also process amendments and will have a key role in making sure that study information is maintained on databases to accurately reflect CRF activity. The post holder is responsible for ensuring the regulatory aspects of clinical trials are maintained to Good Clinical Practice (GCP) standards.The post holder will be based primarily at the Leonard Wolfson Experimental Neurology Centre and will be dedicated to work on a portfolio of a single sponsor. Supporting all aspects of non-clinical coordination, data collection, data reporting and finances. This will be an all-encompassing role, which includes support from study start up to close-out.
Main duties of the job
Lead on the set-up of trials within the CRF with a single sponsoro To be the point of contact for the sponsor, research team, investigatorso Prepare documentation and apply for ethics, Competent Authority and HRA approvals, local feasibility, Assess Arrange and Confirm requirements, and NIHR CRN adoption including substantial amendments, as required.o Assist with project costings at the proposal stage, monitor trial grants, review expenditure against budget and ensure adherence to terms of all relevant contracts, in collaboration with relevant CRF staff and the JRO.o Act as the key and central point of contact for trial specific queries, and support trial Principal and Chief Investigators throughout the clinical trial process, including supporting Site Qualification and Initiation Visits as needed, monitoring visits, collating and distributing essential trial paperwork and other tasks related to trial progress at all stages of the trial life-cycle.o Act as liaison between JRO, PI, sponsor and/or CRO to ensure that any queries are dealt with in a timely manner.o Execute SLA's and reviews with support departments and other Trusts.o Oversee, facilitate and actively engage in data collection, data entry/management, statistical analysis, report writing and trial archiving activities - contributing directly to those activities as required.o Contribute to all non-clinical aspects of conducting studies at site
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 Throat, Nose and Ear Hospital
Eastman Dental Hospital
Royal London Hospital for Integrated Medicine
University College Hospital Macmillan Cancer Centre
The Hospital for Tropical Diseases
University College Hospitals 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.
At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.
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
- 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 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)
Desirable
- Excellent working knowledge of EU pharmacovigilance requirements.
Experience
Essential
- Significant experience of working in a clinical trials setting
- Experience of setting up commercial and noncommercial clinical trials
- 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.
Skills and Abilities
Essential
- Excellent administrative and organisational skills
- Ability to prepare reports
- Resourceful and able to act on own initiative, checking with the line manager when appropriate
- 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 in spite of 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.
- Excellent IT skills , including Word, Excel, PowerPoint, Access/databases and the Internet/email
Communication
Essential
- Ability to write in a scientific, concise, technical and cohesive manner
- Proven ability to communicate effectively verbally
Personal and People Development
Essential
- Demonstrates ability to lead and mentor
Desirable
- Demonstrates coaching skills
Responsibilities towards promoting Equality Diversity and Inclusion
Essential
- Demostrates willingness to treat others with dignity and compassion. Places a high value on diversity and fairness. Understands the Equality Act 2010, duties, roles and responsibilities.
Specific Requirements
Essential
Person Specification
Knowledge and Qualifications
Essential
- First degree in scientific/healthcare related discipline or equivalent experience
- 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 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)
Desirable
- Excellent working knowledge of EU pharmacovigilance requirements.
Experience
Essential
- Significant experience of working in a clinical trials setting
- Experience of setting up commercial and noncommercial clinical trials
- 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.
Skills and Abilities
Essential
- Excellent administrative and organisational skills
- Ability to prepare reports
- Resourceful and able to act on own initiative, checking with the line manager when appropriate
- 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 in spite of 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.
- Excellent IT skills , including Word, Excel, PowerPoint, Access/databases and the Internet/email
Communication
Essential
- Ability to write in a scientific, concise, technical and cohesive manner
- Proven ability to communicate effectively verbally
Personal and People Development
Essential
- Demonstrates ability to lead and mentor
Desirable
- Demonstrates coaching skills
Responsibilities towards promoting Equality Diversity and Inclusion
Essential
- Demostrates willingness to treat others with dignity and compassion. Places a high value on diversity and fairness. Understands the Equality Act 2010, duties, roles and responsibilities.
Specific Requirements
Essential
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
NIHR UCLH Clinical Research Facility (CRF)
235 Euston Road
London
NW1 2BU
Employer's website
https://www.uclh.nhs.uk (Opens in a new tab)
