clinical research associate Nottingham, England
Job description
NHS AfC: Band 7
Job overview
Are you passionate about clinical research? Are you a self-motivated and enthusiastic team member with extensive experience of working in clinical trials? Do you have a passion for research and want to build on our existing gastroenterology portfolio? If this is you, we will be delighted to hear from you.
The Nottingham University Hospitals Research and Innovation department is undergoing a redesign to bring research closer to our patients. Our vision is to situate Nottingham University Hospitals Trust at the very forefront of clinical research placing patient needs at the centre of our research activity.
We are seeking someone to lead our Gastroenterology research team, to grow the portfolio and facilitate the delivery of clinical excellence within clinical trials.
Main duties of the job
In addition to the below summary you need to familiarize yourself with full Job Description and Person Specification documents attached to this advert.
You will work closely with the Divisional Research Delivery Manager providing clinical expertise and support in NUH clinical research projects in developing the Gastroenterology portfolio. You will manage and lead a multi-disciplinary team of research staff and at times work alongside them to support studies. You will ensure that NIHR portfolio studies are run to the highest standards incorporating Good Clinical Practice Guidelines. You will also ensure that the highest standard of participant care is achieved within the clinical area.
The post holder will be based at QMC campus but expected to work across all NUH sites.
Working for our organisation
We are changing the lives of millions of people through outstanding clinical research developed by world-leading clinicians, academics and scientists in Nottingham. Nottingham University Hospitals NHS Trust is one of the biggest and busiest acute hospitals in England, employing over 16,000 staff. We provide care to over 2.5million residents of Nottingham and its surrounding communities and specialist services to a further 3-4million people from neighbouring counties. Clinical research is central to the care we provide for every patient. We deliver over 400 clinical trials across all specialties working as part of the healthcare team, and supported by experts in every part of the research process. Our NIHR Nottingham Biomedical Research Centre is translating research discoveries into new treatments for common diseases including asthma and arthritis.
Our expertise and resources are at the forefront of COVID-19 research into effective treatments and vaccines, as well as contributing to the world's understanding of Coronavirus. Through our dedicated Research Futures multi-professional school, we support the development of knowledge, skills and careers for all clinical and non-clinical roles in research. Our vision is to drive the next generation of scientific discovery and enable every member of our research workforce to realise their full potential.
Detailed job description and main responsibilities
Detailed job description and main responsibilities
To carry out appraisal & development reviews for Research Nurses/Staff, including KSF, in line with Trust policy
To support the Divisional Research Delivery Manager in providing effective leadership, supervision, and line management, of the Gastroenterology Clinical Research Team, and other members of the wider NUH research team; this will include Research Nurses, AHPs, Data Managers and associated staff. (Such staff are referred to in this document as Research Nurses/staff).
To assist the Divisional Research Delivery Manager to monitor and manage Research Nurse/Staff staffing levels for all Surgery Division Portfolio studies.
To assist the Divisional Research Delivery Manager with ensuring NUH Mandatory training needs are met within the Surgery Division Team of Research staff.
To ensure that all Research Nurses/Practitioners/Allied Health Professionals and Investigators are practicing in line with recommendations of ICH Good Clinical Practice (GCP) and to identify and respond to areas of training need.
To assist the Divisional Research Delivery Manager with the recruitment and selection, development, training and retention of relevant staff and all other aspects of people management including performance management, sickness etc.
To advise Senior Clinical Nurses, Lead Clinicians, Service Managers and Scientists of any research issues and changes in practice that may be relevant to their work or have resource, service or research implications.
To ensure that clinical study recruitment records are accurately maintained.
Manage time and resources effectively including chairing relevant meetings, taking minutes and keeping accurate records.
To access the computer network as required to access relevant information.
To work as part of the NUH R&I management team and contribute to the ongoing development of the NUH Research Strategy.
To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
Deputise for the Divisional Research Delivery Manager at meetings as directed.
To be responsible for maintaining strong relationships and positive communication channels with clinical directorates, other key personnel and commercial sponsors.
Clinical Responsibilities and Duties
To act as a Research Nurse, attending and supporting patients in the clinical environment for monitoring, assessment and follow up as part of research projects.
To identify and screen patients for studies and databases.
To co-ordinate your own case-load of clinical studies and the participants.
To ensure clinical trial protocols are adhered to.
To ensure that you are working according to ICH Good Clinical Practice and Research Governance standards for clinical studies.
To ensure trial participants are managed safely according to Trust policies and guidelines.
To register/randomise participants into studies and to be involved in the informed consent process.
To liaise with external clinical study personnel as necessary.
To supply data as required to the PI regarding progress of clinical studies.
To identify barriers to recruitment to studies and ensure that the Principle Investigator is aware of them. Identify and implement action/plans as required to remove these barriers.
To identify to the Divisional Research Delivery Manager /Clinical Lead any future staffing needs which may impact on ability to deliver studies on time
To provide support for clinical research colleagues in their absence.
To attend meetings relevant to the nature of the post.
To ensure the safe administration of treatments and drugs within the context of a clinical study.
To ensure that study specific investigations are undertaken as required by the protocol, in order to establish eligibility and safety to enter the trial.
To provide ongoing information, education and support to volunteers regarding clinical studies.
To ensure blood and other samples are collected for pharmacokinetic studies as required by the study protocol.
To maintain accurate documentation of research related activities in Study, Nursing and Medical notes.
To accurately record data collected in the Case Report Forms (CRF).
To monitor treatment toxicity / side effects and initiate changes to treatment as required by the protocol.
To record and report adverse events to the relevant personnel and take any necessary action.
To report and record serious adverse events to the Trial Co-coordinator/Principal Investigator (PI) and relevant local personnel / Regulatory Authorities.
To provide ongoing follow up care whilst a subject is in a clinical study.
To act as a primary contact point for patients/subjects in a clinical study.
To follow appropriate Trust Policies and Procedures and to ensure that you are working according to Good Clinical Practice and Research Governance standards for clinical studies
To ensure all necessary Regulatory items are in place prior to study commencing.
To ensure that clinical studies are archived as required.
Person specification
Qualifications
Essential criteria
- Registered to relevant Directory or professional body
- Educated to degree level or equivalent demonstrable experience
- Evidence of training undertaken in research governance and regulations, for example, Good Clinical Practice and EU Clinical Trials Directive
Desirable criteria
- Management Qualification or training
- Relevant teaching and assessing qualification
Experience
Essential criteria
- Experience in clinical research role on band 6 or above including providing ongoing care for clinical trial participants
- Experience of working in multidisciplinary teams and able to respect others knowledge
- Demonstrable outstanding organisational and time management skills
- Knowledge of research methodologies
- Demonstrable experience in the management of a broad portfolio of trials
Desirable criteria
- Management experience working in a leadership capacity
- Experience in developing, implementing and following standard procedures
- Experience of the research approval process
Skills
Essential criteria
- Excellent interpersonal verbal, written communication and listening skills
- Ability to build good working relationships, and gain the confidence of others
- Excellent organisational, problem solving and negotiation skills
- Ability to use initiative and work autonomously to tight deadlines
- Displays an awareness and understanding of effective resource management, health and safety, clinical risk and quality issues
Desirable criteria
- Project management experience
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Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at the NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.
Closing Dates: Please submit your application form as soon as possible to avoid disappointment; we reserve the right to close vacancies prior to the published closing date if we receive a sufficient number of completed application forms.
Communication: All communication related to your application will be via the email address you have provided. Please ensure you check your email account including your junk email regularly.
Easy read application: if you have a disability and find it difficult to complete our online application form, you can apply via our easy read application which you can find on the intranet https://www.nuh.nhs.uk/easy-read-job-application
Support with Applications and Interviews: NUH are now able to offer application completion support and interview preparation support. If you would like to be contacted to take up this offer please email [email protected] providing your name, phone number, and email address and the team will be in touch.
Salary: The quoted salary will be on a pro rata basis for part time workers.
Disability Confidence: All applicants who have declared a disability and who meet the essential criteria for the post will be shortlisted.
At Risk of redundancy: NHS employees within the East Midlands who are ‘at risk’ of redundancy will be given a preferential interview where they meet the essential criteria of the person specification.
International Recruitment: If you are applying for a role with us from outside of the UK then please read the guidance on applying for a health or social care job in the UK from abroad.
ID and Right to work checks: NUH authenticate ID and right to work documentation including passports and driving licenses through a system called Trust ID. NUH will scan your ID and right to work documentation in to the Trust ID system at your face to face ID appointment. The system will run a check against the key security features within your documentation. The system will provide us with an outcome of your check which will be stored securely on your personal file along with all other pre-employment check documentation.
Consent:
- Transfer of information: If I have previous NHS service - I consent to the transfer of my Electronic Staff Record (ESR) data between this and other NHS Trusts. I also consent to the Occupational Health Department confidentially accessing my occupational health records from my current or previous employer in order to check the status of my vaccinations, immunisations s and screening tests as relevant to the post. I understand this is an automated process and the information will only be used for these purposes prior to me taking up the position at NUH.
- Disclosure and Barring Service: Your post maybe subject to a DBS check which incur a cost dependent on the level of check required (£41.90 for enhanced and £21.90 for standard). I agree to reimburse Nottingham University Hospitals NHS Trust the cost of a Disclosure and Barring Service (DBS) check if it is required (by deduction from first month’s pay). Should I decide to withdraw from my job offer, I agree to reimburse Nottingham University Hospitals NHS Trust the cost of the DBS check undertaken by cheque or other agreed method.
