Clinical Research Practitioner

at  Nottingham University Hospitals NHS Trust

The post holder will be a key member of the Family Health Research Team. They will assist in the management, co-ordination and facilitation of clinical trial activities to support delivery of current and future studies in the research team to time and target. They will provide specialist research and clinical care for participants and patients enrolling in a variety of research studies and project.
The post-holder will be required to work flexibly over a five day week, with occasional out of hours working.
The successful candidate will have the opportunity to work on urgent and high priority studies in a wide variety of clinical environments and alongside clinical experts in order to deliver the highest quality experience for patients in research trials within the Trust.
You will need to familiarise yourself with the full job description and person specification documents attached to this advert.
The post holder will be responsible for the running of complex clinical trials both commercial and non-commercial, as well as other types of clinical research in the Trust. You will need knowledge of clinical research studies in the clinical setting and exposure to research conducted in the NHS (on wards / theatres / outpatients etc.). Experience of liaising with and maintaining good working relationships with other health professionals across all clinical disciplines at all levels is essential.
The role may involve completing and submitting documents to obtain local approval; collecting, recording and maintaining data for patients on the NIHR portfolio and other studies, providing guidance to other clinical, administrative and research staff, ensuring & organising research tests and investigations, preparing and shipping samples, and ensuring recruitment into clinical trials meets all targets. The role involves acquiring an in-depth knowledge of trial protocols and their application in practice, research methodology and the requirements of local, national and international research regulations.
The post holder will be working independently and with a wider team, work across both sites (QMC & NCH). Full support and training will be provided by to the post holder.
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, 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. Central to our research is Nottingham’s expertise in Magnetic Resonance Imaging (MRI).
Supporting all of our research is the NIHR Nottingham Clinical Research Facility; providing infrastructure, skills and knowledge essential to the delivery of high quality experimental medicine research for adults and children.
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.
Clinical
Assist research nurses/ACP’s/Clinicians in delivery of patient care to research participants.
Support and co-ordinate obtaining and processing of blood and tissue samples in the clinical setting as well as optimising recruitment via clinics and MDT’s.
Work alongside research nurses ensuring samples are collected and recorded per protocol.
Review and record treatments, adverse events and response to treatment to relevant study
documentation including source data and case report forms including electronic data entry.
Plan, prepare and participate in monitoring visits and respond to trial data queries.
Communication
To function as a member of the Research and Innovation Clinical Trials Team to provide
dedicated clinical trials support to research teams across NUH. Working within a multidisciplinary team, to co-ordinate a caseload of patients participating in local, national and
international clinical trials in various treatment types.
. Disseminate information to consultants regarding new trials on the National Institute of
Health Research trial portfolio as well as non-adopted clinical trials, to enable optimal patient
recruitment.
Ensure ethics and R&D approval and indemnities are in place before recruitment of first
patients to a newly set up trial. Facilitate the set-up of trials on site i.e. SSI submission via
IRAS account, liaise with trial centre and other relevant staff to organise trial set-up visits.
Liaise with clinical teams to organise and ensure that trial specific investigations are
undertaken as and when required, obtain the results, ensure eligibility and randomise the
patient.
Liaise with medical staff to record organise and ensure the timely administration of treatment
and any necessary follow up investigations and visits.
Liaise with histopathology ensuring tissue samples are stored via Tissue Bank guidelines,
organising storage and catalogue of samples kept.
To ensure effective communication with support departments to request and obtain specific
trial related information. E.g. Radiology copy scans, histological status and tissue samples.
Organise the collection, storage and shipment of protocol specific samples. Explain,
dispense and collect patient quality of life questionnaires and diaries. Liaise with designated
Pharmacist to co-ordinate the availability and dispensing of trial drugs if required.
Provide information to allow for invoices to be raised for payments where appropriate.
Contribute to and supply verbal and written information on the teams portfolio of trials and the number of patients recruited to the R&I team, hospital/university staff, local/Network meetings, regulatory bodies etc., as required.
Managerial
Maintain patient’s records and accurately document data collected in case report forms and medical notes, ensuring correct storage and maintaining confidentiality.
To record trial activity on data systems and plan yearly Audits on recruitment as required by the clinicians.
Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary.
Attend local and national meetings and feedback to members of the team.
Professional
Work alongside medical and nursing staff to assist in the informed consent process by giving information to patients concerning trials and allowing them to reach a fully informed decision about participation.
To have specific and specialist knowledge of the patient pathway with regard to individual patients diagnosis and the treatment options that are available to them.
Report adverse and serious adverse events to the relevant trial centre and site personnel, within the agreed timelines to ensure trial procedures
and patient safety parameters are met.
Act as a contact point for the patient and their relatives. Maintaining contact with and providing ongoing information and support to the patient in a sensitive and professional manner.
Participate in Continued professional development and undertake additional training as required per Knowledge Skills Framework and research staff competence framework.
Speciality Specific
Assist in the review of trial protocols and identify resource implications for the site.
Identify patients suitable for entry into clinical trials by attending clinics and Multi Disciplinary Team meetings.
Ensure trial protocols are adhered to and that all personnel involved in trials are aware of any changes or protocol amendments. Liaise with trial centres and relevant departments in order to promote a good working environment and ensure the smooth running of clinical trials for
patients.
Work at all times according to regulations described in NUH Policies, procedures and Standard Operating Procedures, Good Clinical Research Practice and European Directive and R&I Standard Operation Procedures

Please refer the Job description for details