Job summary
The Department of Research & Development (R&D) has an opportunity for a Clinical Research Fellow to work in the dedicated Clinical Research Facility (CRF) located at the Northwick Park Hospital Site in Harrow.
The successful candidate will be a GMC registered Medical Practitioner, with relevant and substantial hospital service, including a desire to gain experience managing clinical research patients and healthy participants. Research training will be provided.
The post holder will be responsible for recruitment and consent of trial participants, management of adverse events, protocol review and development, clinical oversight, ensuring all trial conduct is in accordance with GCP and the applicable national regulatory clinical trial standards, and aspects of clinical trial and CRF administrative management.
The post will be part of a multi-disciplinary team consisting of both nursing, allied health professionals, clinical research practitioners/ coordinators and administrative support. The post holder will report to Dr Ashley Whittington, Clinical Lead for the CRF and Consultant in Infectious Diseases and General Medicine.
The exact role will be tailored to the clinical experience and areas of interest of the successful candidate. This would be an ideal opportunity to publish independent research or strengthen a subsequent application to speciality training.
Main duties of the job
Outpatient care of research patients and participants being treated as part of trials performed in the CRF;
Co-ordination and execution of trial activities for the CRF, including (but not limited to) obtaining informed consent for patients, checking eligibility of research patients, randomization, study specific investigations, sample collection and handling, data collection, case record folder completion, maintenance of study documentation;
The post holder will be expected to actively support and participate in both external and internal clinical research monitoring and audits including any regulatory inspections. The post will involve regular liaison with clinical trial sponsors, contract research organisations (CROs) and attendance at site selection and initiation visits.
Under supervision, to undertake the setting up of clinical trials, including where required protocol design, grant applications, regulatory and ethical submissions, liaison with clinical trials units and preparation of study specific documentation.
About us
London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.
Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.
We run major acute services at:
- Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK
- St Mark's Hospital: an internationally renowned specialist centre for bowel disease
- Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice
- Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre.
We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.
Job description
Job responsibilities
1. Post
Clinical Research Fellow in LNWH Clinical Research Facility
There is a 40 hour basic working week and no on-call requirement at present.
2. Location and duration of appointment
12 months fixed term with possible extension subject to funding and performance.
3. Clinical & Research Responsibilities
Outpatient care of research patients and participants being treated as part of trials performed in the CRF;
Co-ordination and execution of trial activities for the CRF, including (but not limited to) obtaining informed consent for patients, checking eligibility of research patients, randomization, study specific investigations, sample collection and handling, data collection, case record folder completion, maintenance of study documentation;
The post holder will be expected to actively support and participate in both external and internal clinical research monitoring and audits including any regulatory inspections. The post will involve regular liaison with clinical trial sponsors, contract research organisations (CROs) and attendance at site selection and initiation visits.
Under supervision, to undertake the setting up of clinical trials, including where required protocol design, grant applications, regulatory and ethical submissions, liaison with clinical trials units and preparation of study specific documentation.
The post holder's duties will be primarily located at Northwick Park Hospital but their presence may from time to time be required in other parts of the Trust.
1. NIHR and commercial studies
The research fellow will be expected to continue participation of the LNWUH in NIHR portfolio studies and/or relevant commercial studies. This will involve recruiting patients to studies and developing strategies to ensure patient enrolment is meeting targets. The research fellow will work closely with the R&D department to ensure study delivery maintains research governance standards which is key to Trust research performance. The research fellow will also be involved in identifying new studies, examining the feasibility of participation of these studies, facilitating set up of new studies and then supervising their implementation until study completion. This role supports an ongoing sustainable research programme which funds the research in the department through ongoing research activity. Close working with R&D and the relevant staff supporting the Trusts research will be key to a successful outcome.
1. Clinical work
You will not be expected to do routine clinical work but may be asked to help in exceptional circumstances. There is an opportunity to undertake weekly clinical sessions in a desired speciality if the candidate desires to broaden their clinical experience.
Job description
Job responsibilities
1. Post
Clinical Research Fellow in LNWH Clinical Research Facility
There is a 40 hour basic working week and no on-call requirement at present.
2. Location and duration of appointment
12 months fixed term with possible extension subject to funding and performance.
3. Clinical & Research Responsibilities
Outpatient care of research patients and participants being treated as part of trials performed in the CRF;
Co-ordination and execution of trial activities for the CRF, including (but not limited to) obtaining informed consent for patients, checking eligibility of research patients, randomization, study specific investigations, sample collection and handling, data collection, case record folder completion, maintenance of study documentation;
The post holder will be expected to actively support and participate in both external and internal clinical research monitoring and audits including any regulatory inspections. The post will involve regular liaison with clinical trial sponsors, contract research organisations (CROs) and attendance at site selection and initiation visits.
Under supervision, to undertake the setting up of clinical trials, including where required protocol design, grant applications, regulatory and ethical submissions, liaison with clinical trials units and preparation of study specific documentation.
The post holder's duties will be primarily located at Northwick Park Hospital but their presence may from time to time be required in other parts of the Trust.
1. NIHR and commercial studies
The research fellow will be expected to continue participation of the LNWUH in NIHR portfolio studies and/or relevant commercial studies. This will involve recruiting patients to studies and developing strategies to ensure patient enrolment is meeting targets. The research fellow will work closely with the R&D department to ensure study delivery maintains research governance standards which is key to Trust research performance. The research fellow will also be involved in identifying new studies, examining the feasibility of participation of these studies, facilitating set up of new studies and then supervising their implementation until study completion. This role supports an ongoing sustainable research programme which funds the research in the department through ongoing research activity. Close working with R&D and the relevant staff supporting the Trusts research will be key to a successful outcome.
1. Clinical work
You will not be expected to do routine clinical work but may be asked to help in exceptional circumstances. There is an opportunity to undertake weekly clinical sessions in a desired speciality if the candidate desires to broaden their clinical experience.
Person Specification
Qualifications
Essential
- MBBS (or equivalent)
- MRCP UK (or equivalent)
- GMC
Desirable
Knowledge
Essential
- Completed Foundation Training
- Experience in Clinical trials and Research
- Experience in Management of acute medical emergencies
Desirable
- Completed core medical training
- Experience in urgent public health & vaccine research
Management and Audit
Essential
- Awareness of clinical governance
- Personal involvement in audit project(s)
Desirable
- Principal investigator in research project
- Experience in feasibility and recruitment planning in clinical research
- Involvement and Understanding of the operational functions and management of clinical research facilities
Research / Publications
Essential
- Keen interest in clinical research and appreciation of major research questions
- Experience and knowledge of clinical trial methodology including the conduct of early and late phase trials
Desirable
- Awareness of Research Governance and GCP training
- Knowledge of IRAS and ethics/HRA approval
Language
Essential
- Able to speak and write English to fulfil job requirements
Personal Skills
Essential
- Effective team member with good communication skills
- Good organisational skills
- Self-starter who completes tasks set by themselves and supervisors
- Flexibility and adaptability
Person Specification
Qualifications
Essential
- MBBS (or equivalent)
- MRCP UK (or equivalent)
- GMC
Desirable
Knowledge
Essential
- Completed Foundation Training
- Experience in Clinical trials and Research
- Experience in Management of acute medical emergencies
Desirable
- Completed core medical training
- Experience in urgent public health & vaccine research
Management and Audit
Essential
- Awareness of clinical governance
- Personal involvement in audit project(s)
Desirable
- Principal investigator in research project
- Experience in feasibility and recruitment planning in clinical research
- Involvement and Understanding of the operational functions and management of clinical research facilities
Research / Publications
Essential
- Keen interest in clinical research and appreciation of major research questions
- Experience and knowledge of clinical trial methodology including the conduct of early and late phase trials
Desirable
- Awareness of Research Governance and GCP training
- Knowledge of IRAS and ethics/HRA approval
Language
Essential
- Able to speak and write English to fulfil job requirements
Personal Skills
Essential
- Effective team member with good communication skills
- Good organisational skills
- Self-starter who completes tasks set by themselves and supervisors
- Flexibility and adaptability
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).