Detailed job description and main responsibilities
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
* Function as a member of the Research and Innovation Clinical Trials Team to provide dedicated clinical trials support to research teams across NUH.
* Work 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.
* Ensure effective communication with support departments to request and obtain specific trial-related information.
* 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 team's 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.
* 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.
* 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 Operating Procedures.
Person specification
Knowledge, Training, Qualifications
Essential criteria
* Educated to diploma level or equivalent level of experience.
* A good level of IT skills demonstrated by competence in Microsoft software packages i.e. outlook, word processing, database and spreadsheets.
Desirable criteria
* Appropriate further education or development.
* Research qualification.
Communication skills
Essential criteria
* Excellent communication and interpersonal skills, both written and verbal, in order to undertake own job and inform work colleagues, external bodies, and various hospital departments.
* Able to display empathy, tact, reassurance and diplomacy when receiving and providing information.
* Ability and experience of working as part of a team.
Analytical skills
Essential criteria
* Ability to assess, evaluate and interpret clinical/non-clinical information and events against defined protocols in order to determine the appropriate course of action.
Planning and organisational
Essential criteria
* Good organisational and time management skills in order to prioritise own workload.
* Able to work to strict deadlines and set timeframes.
Experience
Essential criteria
* Comprehensive administrative/data management experience - preferably in an NHS setting or a busy office environment.
* Experience in a working environment that involves patient/customer care.
* Knowledge of clinical trials.
* Clear understanding of the importance of confidentiality.
Desirable criteria
* Experience of working in a NHS setting.
* Experience of working within a clinical trial setting.
* Knowledge of research governance and regulations (e.g. ICH-GCP and EU Directives).
* Experience of research registry databases.
* Experience of working in a paediatric environment.
* Sample preparation & handling.
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 here.
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.
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.
* Disclosure and Barring Service: Your post may be subject to a DBS check which incur a cost dependent on the level of check required (£42.90 for enhanced and £22.90 for standard).
Employer certification / accreditation badges
Applicant requirements
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
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