Job summary
We are looking for a Clinical Trial Manager - the role will be to help deliver the PROTECT-HF trial. The PROTECT-HF Trial is a major multicentre clinical trial which is likely to lead to a change in worldwide practice in the field of pacing therapy. The trial will establish whether conduction system pacing (a new way of delivering ventricular pacing) improves outcomes compared to standard right ventricular pacing.
Main duties of the job
You will have a pivotal role assisting in the set-up of the study both in the UK and internationally and ensuring ongoing regulatory approvals are in place. You will be responsible for assessing and managing the care pathways for research patients. This will involve establishing feasibility, pre-study set-up, recruitment, coordinating investigations and follow-up visits.
About us
Our section works on questions of immediate, practical value to cardiac patients and their doctors. Our researchers include a wide variety of subspecialties of cardiology, spanning the spectrum from specialists in efficient cardiovascular prevention, to reliable diagnostics (addressing cardiac imaging, human performance enhancement and machine-learning with neural networks), and effective treatments (including medication, coronary stenting, pacemakers and defibrillators and arrhythmia ablation). At almost any hour of day or night, there will be one of our team up to something, somewhere in the university or hospital.
We are happy to address research ideas at any stage where we can make a unique contribution. This could be from their earliest origination, for example, mathematical modelling for population health, through to inventing novel diagnostic or therapeutic techniques, or conducting first-in-human studies, and ultimately managing large-scale clinical trials.
The touchstone of our research is to ensure the results are reliable. This means attention to detail in research design and methodology, and honest and clear reporting of results even when they are not what we hoped for. We would stake our own lives on our research findings, because ultimately we are expecting patients to do so.
Job description
Job responsibilities
A sound knowledge of and experience in cardiovascular nursing
Practical experience within a research environment;Knowledge of research governanceDemonstrated ability to interact well with other team membersExperience of managing patient caseloadsAwareness of resources and the ability to operate within a financial budgetA knowledge of Good Clinical Practice (GCP) in the context of clinical trialsExperience of patient recruitmentThis position is full-time, fixed-term: until 30th September 2028 based at Hammersmith Campus (East Acton). All candidates need to complete an online application. The College is a proud signatory to the San-Francisco Declaration on Research Assessment (DORA), which means that in hiring and promotion decisions, we evaluate applicants on the quality of their work, not the journal impact factor where it is published. For more information, see https://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-evaluation/ As this post is exempt from the Rehabilitation of Offenders Act 1974, a satisfactory Disclosure and Barring Service (DBS) check, at the appropriate level, will be required for the successful candidate. The College believes that the use of animals in research is vital to improve human and animal health and welfare. Animals may only be used in research programmes where their use is shown to be necessary for developing new treatments and making medical advances. Imperial is committed to ensuring that, in cases where this research is deemed essential, all animals in the College's care are treated with full respect, and that all staff involved with this work show due consideration at every level. http://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-integrity/animal-research/ Imperial College is committed to equality of opportunity, to eliminating discrimination and to creating an inclusive working environment. We are an Athena SWAN Silver award winner, a Stonewall Diversity Champion, a Disability Confident Employer and work in partnership with GIRES to promote respect for trans people.
Job description
Job responsibilities
A sound knowledge of and experience in cardiovascular nursing
Practical experience within a research environment;Knowledge of research governanceDemonstrated ability to interact well with other team membersExperience of managing patient caseloadsAwareness of resources and the ability to operate within a financial budgetA knowledge of Good Clinical Practice (GCP) in the context of clinical trialsExperience of patient recruitmentThis position is full-time, fixed-term: until 30th September 2028 based at Hammersmith Campus (East Acton). All candidates need to complete an online application. The College is a proud signatory to the San-Francisco Declaration on Research Assessment (DORA), which means that in hiring and promotion decisions, we evaluate applicants on the quality of their work, not the journal impact factor where it is published. For more information, see https://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-evaluation/ As this post is exempt from the Rehabilitation of Offenders Act 1974, a satisfactory Disclosure and Barring Service (DBS) check, at the appropriate level, will be required for the successful candidate. The College believes that the use of animals in research is vital to improve human and animal health and welfare. Animals may only be used in research programmes where their use is shown to be necessary for developing new treatments and making medical advances. Imperial is committed to ensuring that, in cases where this research is deemed essential, all animals in the College's care are treated with full respect, and that all staff involved with this work show due consideration at every level. http://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-integrity/animal-research/ Imperial College is committed to equality of opportunity, to eliminating discrimination and to creating an inclusive working environment. We are an Athena SWAN Silver award winner, a Stonewall Diversity Champion, a Disability Confident Employer and work in partnership with GIRES to promote respect for trans people.
Person Specification
Qualifications
Essential
- Bachelor's degree or equivalent in biomedical / scientific field
Desirable
Experience
Essential
- Proven clinical trial / project management experience gained in multi-centre trials
- Working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, GDPR, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trials
- Evidence of preparing regulatory and ethics submissions, writing/amending protocols, patient information sheets, case report forms (CRF) / electronic CRF, and other relevant trial management documentation
- Evidence of strong IT literacy (MS Office)
- Experience of working in a research environment
- Experience of data entry and data management processes using electronic CRF
Desirable
- Experience of working within the NHS or academic clinical research setting
- Demonstrated success in the management of clinical trials budgets
Person Specification
Qualifications
Essential
- Bachelor's degree or equivalent in biomedical / scientific field
Desirable
Experience
Essential
- Proven clinical trial / project management experience gained in multi-centre trials
- Working knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, GDPR, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trials
- Evidence of preparing regulatory and ethics submissions, writing/amending protocols, patient information sheets, case report forms (CRF) / electronic CRF, and other relevant trial management documentation
- Evidence of strong IT literacy (MS Office)
- Experience of working in a research environment
- Experience of data entry and data management processes using electronic CRF
Desirable
- Experience of working within the NHS or academic clinical research setting
- Demonstrated success in the management of clinical trials budgets
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).
