This is an exciting opportunity to join our successful Respiratory Research Team. The post holder will contribute actively to the conduct, coordination and delivery of research, under the leadership of the senior research nurse. Working effectively with the immediate and broader multidisciplinary team, being responsible for ensuring that high standards of clinical care planning, delivery, safety and patient satisfaction is to a very high standard, compliant with trust policy, study protocol requirements, local and national guidance and legislation.
Main duties of the job
The post holder will support the senior research nurse, principal investigators and associated multidisciplinary colleagues in the planning, scheduling, conduct, recruitment, patient care, support and data collection required for all studies within the department. They will be responsible for developing their own clinical practice, maintaining competencies (related to the research portfolio) and where appropriate taking delegated responsibility for the clinical elements of studies in line with trust policies and study protocols.
The post holder will be involved in ensuring that the research undertaken within the department safeguards the wellbeing of patients and is conducted within the confines of the ICH Good clinical practice guidelines for research EU directive, UK.
The post holder will demonstrate a commitment to quality patient care through effective leadership and team working and will work at all times in accordance with the Nursing and Midwifery Code of professional Conduct and relevant professional guidelines.
They will exhibit the Trust's Values and Behaviours and will model the way for others to demonstrate these in their practice.
Job responsibilities
* Develop a balanced portfolio of commercial and non-commercial studies.
* Assess protocols and advise on safety, regulatory and logistical issues for the set up and running of the study/trial to ensure the well-being and safety of patients, participants and staff.
* Perform clinical trial coordinator duties (to include study setup, organisation and contribution to SIVs, project team meetings, delivery study visits) across a wide range of clinical trial areas.
* Plan the management of a specific research study, including the establishment and maintenance of office systems and adherence to project timescales and targets.
* Ensure agreed recruitment metrics are achieved within the agreed timeline.
* Identify barriers to participation in trials and develop strategies with clinicians, Trusts and others to overcome these barriers.
* Use appropriate computer software (EDGE) to process queries and provide reports on patient accrual.
* Participate in update meetings of the project team (both internal and external) to review the progress of specific projects.
* Publicise current trials to encourage new participants to join, and to maintain enthusiasm amongst existing participants by appropriate methods - mainly personal letters and the production of regular newsletters for specific projects.
* Ensure that the data recorded on the case record forms (CRFs) of patients entered into specific trials or research projects are entered completely and accurately and within agreed timelines.
* Ensure that any queries on the CRFs (missing or inconsistent or illegible data) for the specific trials or research projects are dealt with within agreed timelines.
* Provide participants with specialist information regarding their participation, including explaining all risk factors.
* Provide high standards and continuity of care for participants during the research study, maintaining lines of communication with clinical staff.
* Act as a resource to participants, their families and staff from within the clinical area, providing information and support; and to refer to other support agencies where necessary.
* Achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate to the work undertaken.
* Undertake, with appropriate training, interventional treatments directly to participants according to study/trial protocol and procedures and record the resulting information.
* Take and process clinical samples (e.g. venepuncture/cannulation) for studies, coordinate tissue sample collection and dispatch to relevant department or trial centre as appropriate.
* Maintain clinical skills as appropriate e.g. vital sign assessment, patient compliance, ECGs, flow rates and bladder scans.
* Attend relevant outpatient clinics to assist with recruitment, to monitor the progress and to collect data of participants involved in the study/trials.
* Attend inpatients involved in clinical trials as necessary to provide the care needed as prescribed in the protocol.
* Work at all times as part of the extended multidisciplinary team and maintain excellent links with the staff in clinic, ward and treatment areas regarding the protocol care required for study/clinical trial participants.
* Administer trial medications and treatments as appropriate.
* Recognise changes in patients' conditions which require the intervention of others and refer on as appropriate.
* Support patients when receiving sensitive and life-changing health information.
* Contribute to the development, implementation and delivery of training packages.
* Deputise when required for the senior research nurse/AHP as required, involving working with staff at all levels and service users. The post will require high standards of integrity, confidentiality and attention to detail.
Person Specification
Qualifications
* Registered Nurse.
* Recognised teaching/assessing qualification.
* Research qualification (e.g. certificate/MSc in clinical research).
Experience
* Experience of computer databases and administration.
* Working with a wide range of professionals.
* Experience dealing with highly complex situations.
* Experience providing and receiving highly complex information.
* Project management skills and experience.
* Ability to critically analyse research findings.
* Clinical trial research experience.
* Understanding of research methodology.
* Experience of working in the respiratory environment.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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