Job summary
The post holder will work predominantly within the neonatal and paediatric research team to facilitate an expanding and positive research portfolio of studies.
The post holder will work collaboratively with Leading Principal Investigators, Research team and the wider multidisciplinary team to provide an opportunity for patients to participate in research studies. The Research Sister/Charge nurse will lead on complex studies and manage a caseload of their own together with supporting other studies within the bounds of their registration. They will be expected to participate in the recruitment of patients into clinical research, including clinical trials of drugs and new interventions within set time limits. When working on clinical trials he/she will monitor the patients and observe for side effects reporting according to set protocols. An important aspect of the role is the maintenance of accurate and comprehensive records of data derived from the research studies. Therefore the post holder will require excellent documentation, organisational and time management skills.
The post holder will work in conjunction with other team members ensuring all research undertaken within the department safeguards the well-being of the participants and is conducted within the research governance framework.
Main duties of the job
The job holder may be required to carry out other similar or related duties within their bounds of registration which do not fall within the work outlined which may reasonably be required to deliver a comprehensive research service to our patients. The Line Manager, in consultation with the post holder will undertake any review.
Research Teams:
This summary contains the specific detail pertaining to the research team to which the post is attached. It does not affect the core responsibilities as listed, allowing for a core job description to be used across Specialties enabling standardisation of the nurse responsibilities.
The post holder will be employed by Research and Development Department (R&D)to work within the central clinical research teams, predominantly based in the Paediatrics and Neonates departments. However, it is expected that the post holder will work flexibly across other research speciality areas as service requirements dictate throughout the duration of their contract.
They will contribute to the provision of a clinical research service based normally at the location of the employing organisation (UHCW NHS Trust), however, travel to other sites may be required as per study requirements or set out under contractual agreements for the delivery of a local cross cutting clinical research service.
About us
University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.
We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.
Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.
We are proud to be recognised as a Pathway to Excellence designated organisation - please click the link for further details about this prestigious award. Pathway To Excellence - University Hospitals Coventry & Warwickshire (
By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.
The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.
Job description
Job responsibilities
Clinical
1. Ensure care to patients is delivered according to Trust policies and procedures and the research protocol
2. Co-ordinate the care of own case load of clinical trial / research patients in addition to oversight of junior team members caseload
3. Work unsupervised in all areas related to clinical trials and research studies and supervise the work of junior team members
4. Attend Multi-disciplinary Meetings, and appropriate clinics, to assess volunteers/patients for eligibility for research and recruit new patients, to act as a resource to the members of the MDT. Communicate information regarding clinical decisions to patients, carers and the MDT as required
5. Ensure that trial specific clinical investigations / procedures are undertaken as required by the research protocol in order to establish eligibility and maintain safety in the trial
6. Take relevant samples as required by the study protocol such as blood samples, package and dispatch as defined. Ensure safe and appropriate storage of specimens in accordance with trial protocols and regulatory / Trust guidance
7. With relevant training and assessment of competence, working within scope of professional practice, undertake clinical procedures / administer treatments associated with the research treatment regimes
8. Ensure the safe administration of treatments and drugs that are given within the context of a clinical trial.
9. Monitor treatment toxicity/side effects reporting to the relevant personnel, recording as required assisting in any required changes to treatment as required by the protocol
10. Record and report adverse events which occur whilst patient is in the clinical trial to the relevant personnel and act as required
11. Report and record serious adverse events that occur whilst the patient is being treated on a clinical trial to the trial co-coordinator/PI and relevant local personnel/regulatory authorities in a timely manner
12. Maintain accurate documentation of patients events in nursing/medical notes. Accurately document data collected into case report forms either paper or electronically
13. Provide on-going information, education and support to patients (and their significant others) regarding clinical trials and their care. Manage difficult and or unexpected situations arising in the clinical area ( bad news)
14. Provide on-going follow up care whilst patient is in the clinical trial / research studies
15. Refer to other specialists as required in order to provide optimal patient care
16. Act as the primary point of contact for the participant
17. Participate in service and policy development
18. Provide support / cover for colleagues in their absence
Research
19. Ensure that the delivery of studies meet the requirements with regards to the Department of Healths Research Governance Framework for Health and Social Care and the EU Clinical Trials Directive by implementing quality systems
20. Co-ordinate the delivery of a clinical trials portfolio within the relevant specialities
21. Co-ordinate and lead the recruitment and retention of patients into a variety of research studies including but not restricted to clinical trials
22. Participate in Good Clinical Practice training (ICH GCP) as required by the latest guidance
23. Contribute to the process of gaining local regulatory committee approval
24. Assist in the review of study protocols and contribute to the feasibility/study selection process, advising on safety, regulatory and logistical issue
25. Work with the trials teams and investigators to develop strategies to overcome barriers to recruitment and solve other problems relating to specific studie
26. Contribute to the study set up, recruitment planning and study delivery plannin
27. Randomise / enrol patients into clinical trials or other research studie
28. Provide on-going advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consen
29. To facilitate and assist in the informed consent process ensuring that consent forms are completed accurately and filed as required and participants are fully aware of the nature of the stud
30. Following appropriate training and competence assessment obtain written informed consent from participants for allocated research studies in accordance with study protocol and Trust guidanc
31. Ensure clear, concise and accurate records are kept for research projects in accordance with all regulatory requirements including the data protection act
32. Ensure that all ICH GCP required documentation is kept in a clearly traceable system and is stored in an appropriate manner for the appropriate length of tim
33. Where required, data is transcribed accurately into the Trial Master File and maintain in accordance with ICH GC
34. Plan, prepare and participate in monitoring and audit visits. Respond to data queries generated by the study co-ordinating team within a timely manner. Liaises with trial personnel outside of the hospital as necessar
35. Assess and evaluate the progress of on-going trials for which the post holder has responsibility
36. Maintain accurate records of study recruitment as per local procedure and status of studies providing regular updates. This will involve ensuring that EDGE (local patient management system) is updated with key trial data and feeding back through the local portfolio team meeting
37. Utilise and ensure others utilise information and IT systems to secure accurate and timely patient, workforce and resource dat
38. Escalate on-going study performance issues to the Senior Research Sister/Charge Nurse in a timely manne
39. Safeguard the integrity of the study by ensuring compliance with ICH GCP guideline
40. Co-operate with external and internal audit, data monitoring and quality assurance by working with RD&I, Sponsors, study monitors and external bodie
41. Assist in study close down procedures.
Management
42. Manage a designated number of studie
43. Recognise and report / manage any complaints from patients/ carers
44. Take responsibility for the supervision of junior research nurses and act as a resource to ensure they optimise their clinical research skills and potential.
45. Assist in the education and support of other health care professionals to enable them to care for patients participating in clinical trials or other research studies
46. Respond to change in line with the needs of the service
47. Use judgement in relation to competing demands for staff and resources
48. Assist in the effective recruitment and selection of staff in line with the Trusts recruitment and Selection process as require
49. Assist in the Trust performance review process for junior research nurses and other appropriately allocated staff within the team
50. Ensure performance issues within the team are dealt with in an appropriate and timely manner by escalating issues to the responsible Senior Research Nurse
Personal education and development
51. Keep updated with Departmental, Trust, NHS and relevant statutory developments for the management of clinical research
52. Maintain an up to date knowledge of research related articles particularly related to clinical trials and research studies
53. Be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with NMC requirements
54. Maintain links with other research nurses and multidisciplinary teams across the Trust and network to share knowledge and to provide mutual support
55. Attend local Trust and national meetings in relation to research trials as appropriate and agreed with line manage
Other:
56. To work within the NMC Code of Conduct and within individual scope of professional conduct
57. Undertake all Trust mandatory training as per Trust procedures and policies
58. To maintain patient confidentiality at all times.
For full job description please see attached in supporting information
Person Specification
Qualifications
Essential
59. See supporting documents
Desirable
60. See supporting documents
Experience
Essential
61. See supporting documents
Desirable
62. See supporting documents
Knowledge
Essential
63. See supporting documents
Desirable
64. See supporting documents
Skills
Essential
65. See supporting documents
Desirable
66. See supporting documents