Job responsibilities
CLINICAL
1) Responsible for providing an efficient and high quality service in the field of Respiratory Physiology and to provide the very best care and efficient treatment of patients during their stay in the department.
2) Plan, perform, technically and clinically interpret a range of basic and advanced lung function investigations to a high level of competence on patients, regularly using complex software, and where appropriate create clinical reports.
This includes:
Full lung function tests (spirometry +/- bronchodilator responsiveness testing, lung volumes and transfer factor)
Six-minute walk tests
Oral exhaled nitric oxide tests
Mannitol challenge tests
Induced sputum
Exercise induced bronchoconstriction tests
3) Carry out and document scheduled calibration, maintenance and quality control procedures for any equipment used to ensure that equipment is functioning to agreed standards, providing accurate and safe performance.
4) Have an in-depth knowledge of specialist equipment operation and to use it to its maximum capability.
5) Troubleshoot equipment faults and, if required, to organise equipment repair in order to maintain an efficient service.
6) Assist with the acquisition and distribution of relevant trial documentation/equipment.
7) Maintain trial site files for each trial in accordance with ICH-GCP and research governance.
8) Collection of patient data from medical notes and completion of case record forms (CRFs) and to liaise with clinical trial coordinators, research nurses and investigators to ensure accurate data collection
9) Organise and prepare for visits by trial monitors as required by the study protocol
10) Take responsibility for liaising with clinical trials units/study sponsors regarding data query resolution.
11) Evaluate patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocols.
12) Ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent)
13) Attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects
14) Where appropriate, to take consent from patients/participants to enter research studies
15) Collect relevant patient samples for clinical trials, such as blood and urine
16) Observe patients and monitor treatment toxicity/side effects, escalating findings accordingly
17) Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes
18) Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner
19) Ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist teams
20) Record and report any adverse and serious adverse events according to trial protocol and local procedure.
21) Contribute to effective communications within the team, including preparation and delivery of regular presentations and reports.
22) Establish and maintain effective working relationships with all relevant organisations and individuals, including member NHS Trusts, other NIHR Clinical research networks and other providers of NHS services within the RDN, Clinical Trials Units, CRDC, Industry, and NHS commissioners.
R&I DIRECTORATE
1. Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Manager. Participates in the development of an agreed personal development plan to meet identified needs.
2. Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to.
3. Participate in the implementation of research practice standards.
4. Responsible for remaining adequately informed of clinical trials, R&I activity and the Trust by attendance at team brief and using other appropriate forms of communication.
5. To undertake mandatory training as required by the individual Trusts and additional clinical, research and IT training as required by the research studies
6. Work to SOPs, applicable regulatory requirements and laws as per required and applicable to each research study, department and Trust
7. Ensure relevant approvals are in place prior to commencing each trial.
8. Ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines.
9. Observe patients and monitor treatment/toxicity side effects, escalating findings accordingly.
10. Provide education and support for patients in research trials
11. Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial.
12. Work with the Ethics and Governance team to ensure all clinical trial documentation has appropriate ethical committee and Trust approval providing feedback to the lead clinician and research directorate.
13. Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities.
14. Provide on-going audit reports as required by the trial protocols and Research & Innovation department/ethics committee.
15. Responsible for resolving data queries raised by sponsoring organisations.
16. Provide mentorship and supervision for other research professionals and staff within and outside the department.
17. Act as a resource for ward based nurses/ allied health professionals wishing to undertake/support research once competencies have been achieved.
18. Act as a role model for excellence in research.
