Senior Research Nurse/AHP - Respiratory Research - NHS
NHS Jobs Bristol
Please see Full JD for more descriptions. The Post holder will: Act as an expert resource and is responsible for ensuring all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation.
Be responsible for ensuring the feasibility procedures undertaken are sufficient to ensure all studies undertaken are within the scope of the unit and the available resources. Support the PI and trials team in ensuring research trials are run in line with regulatory requirements.
Be responsible for ensuring all studies are registered with the R+D department and that full Trust approval, in addition to ethics approval, has been obtained prior to commencement of the study. Work with the R+D department in contract negotiations Liaise with the NIHR Clinical Research Network throughout the study and facilitate the lines of communication between the Trust / R+D and the NIHR CRN.
Has a comprehensive knowledge of the financial issues relating to the undertaking of clinical research. Be expected to undertake detailed costing of studies to ensure all costs related to the study are identified prior to Trust approval being given.
Involved in the financial processes associated with co-ordinating research studies. Be responsible for project managing all the studies in set up, Is expected to identify any blockages to study set up and work with R+D to identify strategies to mitigate them.
Is expected to establish and update Standard Operating Procedures and supporting the development of local and national policies for research. Ensure compilation and maintenance of all site files, in accordance with ICH-GCP. Maintain a register and documentation of ICH-GCP for all research active staff, including documentation of ongoing training pertaining to their specific studies.
Lead and line manage a team of research delivery staff to deliver a portfolio of clinical research. Budget management. Clinical Trial Running Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations Ensure correct maintenance of Investigator Site File(s) and completion of Case Report File / eCRF with a high degree of accuracy.
To understand and apply in practice the legal and regulatory requirements related to gaining and maintaining valid informed consent. This will include, where appropriate, children, young people, and vulnerable adults. Project manage the assignments to ensure all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol.
Acts in the best interests of the research subjects to ensure their rights are upheld. Ensure Protocol amendments are incorporated into research practice. Acts as an expert resource for staff in relation to the financial management of clinical research studies.
Uses expert judgement in relation to competing demands for funding / resources Acts as an expert resource to PIs in ensuring all Adverse Events and Serious adverse events are reported in line with ICH-GCP, ISO 14155 and Trust policy. Is expected to identify any blockages to recruitment and the running of the trial and work with R+D, and where appropriate liaise with the NIHR Clinical Research Network, to identify strategies to mitigate them.
Ensure that all equipment used in all the trials are appropriately calibrated and be responsible for the retention of supporting documentation. Support the PI in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner.
Be responsible for ensuring the submission of monthly recruitment / accrual figures to the appointed person at NBT / NIHR Clinical Research Network Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
Be responsible for ensuring the feasibility procedures undertaken are sufficient to ensure all studies undertaken are within the scope of the unit and the available resources. Support the PI and trials team in ensuring research trials are run in line with regulatory requirements.
Be responsible for ensuring all studies are registered with the R+D department and that full Trust approval, in addition to ethics approval, has been obtained prior to commencement of the study. Work with the R+D department in contract negotiations Liaise with the NIHR Clinical Research Network throughout the study and facilitate the lines of communication between the Trust / R+D and the NIHR CRN.
Has a comprehensive knowledge of the financial issues relating to the undertaking of clinical research. Be expected to undertake detailed costing of studies to ensure all costs related to the study are identified prior to Trust approval being given.
Involved in the financial processes associated with co-ordinating research studies. Be responsible for project managing all the studies in set up, Is expected to identify any blockages to study set up and work with R+D to identify strategies to mitigate them.
Is expected to establish and update Standard Operating Procedures and supporting the development of local and national policies for research. Ensure compilation and maintenance of all site files, in accordance with ICH-GCP. Maintain a register and documentation of ICH-GCP for all research active staff, including documentation of ongoing training pertaining to their specific studies.
Lead and line manage a team of research delivery staff to deliver a portfolio of clinical research. Budget management. Clinical Trial Running Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations Ensure correct maintenance of Investigator Site File(s) and completion of Case Report File / eCRF with a high degree of accuracy.
To understand and apply in practice the legal and regulatory requirements related to gaining and maintaining valid informed consent. This will include, where appropriate, children, young people, and vulnerable adults. Project manage the assignments to ensure all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol.
Acts in the best interests of the research subjects to ensure their rights are upheld. Ensure Protocol amendments are incorporated into research practice. Acts as an expert resource for staff in relation to the financial management of clinical research studies.
Uses expert judgement in relation to competing demands for funding / resources Acts as an expert resource to PIs in ensuring all Adverse Events and Serious adverse events are reported in line with ICH-GCP, ISO 14155 and Trust policy. Is expected to identify any blockages to recruitment and the running of the trial and work with R+D, and where appropriate liaise with the NIHR Clinical Research Network, to identify strategies to mitigate them.
Ensure that all equipment used in all the trials are appropriately calibrated and be responsible for the retention of supporting documentation. Support the PI in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner.
Be responsible for ensuring the submission of monthly recruitment / accrual figures to the appointed person at NBT / NIHR Clinical Research Network Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
Always observes the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations. Communicates to R+D / NIHR Clinical Research Network lead regarding research subjects, trial progress, workload issues and personal development.
University Hospitals Bristol and Weston NHS Foundation TrustBristol
of each day. Research nurses need to be flexible in their work patterns in order to deliver this service if the studies require.It is expected that the research nurse will lead on a portfolio of paediatric research studies.
The post holder...
NHS JobsNewport, 21 mi from Bristol
The role of the Clinical Research Nurse/AHP is to take responsibility for the identification of clinical trials appropriate for our clinical services, the facilitation of these trials and once open, their ongoing management and care of patients...
NHS JobsNewport, 21 mi from Bristol
The role of the Clinical Research Nurse/AHP is to take responsibility for the identification of clinical trials appropriate for our clinical services, the facilitation of these trials and once open, their ongoing management and care of patients...