Senior Research Nurse/ Practitioner
The post holder will be working on a variety of mental health and dementia studies including the ASSURED study; a randomised controlled trial of a brief psychological intervention for people presenting to emergency departments with self-harm.
This will involve close working with Liaison Psychiatry. Research will be conducted in accordance with the Research Governance Framework, and for clinical trials in accordance with the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines and regulatory requirements to provide assurance that the rights, safety and well being of trial participants are protected.
The post holder will use relevant knowledge to perform all research procedures according to protocols and extend this experience to support others in the research team and other health care professionals where appropriate. They will be accountable for the assessment, planning, organisation and ongoing care of research participants, whilst maximising compliance.
You will help raise awareness of research amongst clinical colleagues and service users, and will help to embed research within clinical teams by regularly attending clinical team meetings. The studies we support range from observational to interventional studies and may include commercial clinical trials of investigational medicinal products.
The Clinical Research Nurse/ Senior Research Practitioner will be based at Wonford House Hospital, Exeter. The post holder may also be required to provide support for other studies conducted at other NHS trusts within the geographical region of the South West Peninsular, therefore the ability and willingness to travel is a requirement of the role.
Duties and Responsibilities Communication with: Mental Health Clinical Research Teams across the Peninsula Local Clinical Research Network: South West Peninsula Mental Health Network Manager Research Team Members Medical Staff Nursing and Therapy Staff Research and Development Office Staff Research Pharmacy Technician Patients and Relatives/Carers Secretarial, Administrative and Clerical Staff Diagnostic Services Research Ethics Committee External Pharmaceutical Clinical Research Associates and monitors Clinical Trial participants and their families GPs and Practice Nurses Academic staff and research staff in the Partnership Universities Staff on Mental Health research projects NIHR Clinical research network :mental health Coordinating Centre staff Other CSOs and Clinical Research Nurses based across the UK.
Regard effective communication as a key to successful care delivery Research Study specific responsibilities Provide information and support to patients and carers relating to the research protocol, procedures and treatment, follow-up and ensure that informed consent is obtained.Deal with enquiries from other Health Care Professionals, patients and carers Contribute clinical trials/research expertise within the Trust. Take blood samples where indicated and ensure they are properly prepared, stored and despatched where appropriate.
If appropriate to the protocol and within the scope of practice and competency, administer study medication or teach patients where appropriate and monitor for toxicity. Undertake the safe analysis, processing and dispatching of pathological samples and completion of relevant documentation.
Some duties may be necessary after normal working hours therefore some flexibility required in work schedule. Liaise with Research and Development offices during set up period and provide progress reports throughout the project in a timely manner.
Adhere to clinical trial protocols: Eligibility for inclusion Patient randomisation Ensure anonymity of clinical trial patients Data collection and management Entering data into Case Report Forms and on to databases Patient monitoring Study assessments Reporting serious adverse events Participate in meetings with other centres involved in clinical trials and attend investigator meetings.
Identify strategies for recruiting patient into clinical research and provide long term follow up where required Working with R&D Managers, develop, integrate, plan, provide and negotiate resources (financial and physical) across the Trust to support and develop clinical research activity.
Manage a portfolio of clinical trials and research studies running across the Trust. Provide specialist advice and review as necessary by undertaking clinics or during existing appointments, telephone calls and in other clinical settings. Select and recruit participants according to inclusion / exclusion criteria which are study/trial specific by reviewing information, attending clinics and other clinical areas and taking an active role within the multi disciplinary team Safeguard the autonomy and integrity of participants by giving sufficient information to assist in the informed consent procedure Conduct assessments, trial procedures and documentation in strict compliance with the protocol and Trust policy and interpret these results to assess care needs.
Refer patients to other health care professionals as appropriate. Maintain the necessary competency skills in order to comply with protocol requirements Support research participants in making informed treatment choices by providing specialist knowledge in relation to the disease process, treatment options and treatment side effects Undertake care in a manner that is consistent with: Legislation, policies, procedures Patient centred care Compliance with the local delivery of infection control practice An environment that is fit for purpose in delivering safe and effective patient care Individual privacy and dignity Conduct of care Scope of Professional Practice Multidisciplinary Team Working Maintain an awareness of current advances in mental health care, treatment and research practice Expand own knowledge of practice through learning about current clinical and medical developments and research in dementia, mental health and social care, seeking to develop new skills Demonstrate knowledge of research methodology, design and apply evidence-based research findings to professional practice.
Participate in writing, updating and implementing policies, protocols and guidelines for the Trust. Adhere to the IHC guidelines for GCP, regulations and Standard Operating Procedures (SOPs) for clinical research and related activities Ensure the accuracy, completeness, legibility and timeliness of data recorded in all study related reports Maintain participants safety by reporting adverse events according to regulatory and protocol requirements.Ensure study documentation is maintained and complete Assist in establishing and implementing mechanisms and guidelines to enable tracking of research costs. Manage a range of clinical trials laboratory equipment Recognise the value of skilled open communication in the development of healthcare professional-patient relationships and with other members of the multi-disciplinary team.
Provide information and support to patients and their families, involved in research / clinical trials Ensure data is available to consultants, researchers and sponsor companies for audit, quality assurance and analysis Provide information to allow for the raising of invoices relating to trials where appropriate Assist in the review of resource implications for the research sites.
Maintain a safe and therapeutic environment for clinical trial patients and their carers Ensure that Health and Safety requirements are met in the Department Liaise with clinical teams to maintain seamless care Take a proactive role in the NIHR Clinical Research Network: mental health, and liaise with the Research Network managers and colleagues throughout the network to work towards network aims and objectives and contribute information Maintain effective communication channels between the team Actively seek patient/carer feedback Support new and junior team members in the development of knowledge and skills necessary to maintain the quality of research and service delivery Work without supervision and adhere to Clinical Governance initiatives, appropriate code of professional conduct and Trust policies Undertake line management/supervision of junior staff members.
Keep clear, concise records in terms of patient documentation and data collection. Ensure that screening and recruitment data is kept up to date Ensure timely and complete Case Report Form data entry and response to data queries Participate in research meetings and ensure accurate information is fed to the Clinical Research teams