To contribute to all aspects of the planning, conduct, and reporting of all clinical trials within the research based in primary care primarily. To be responsible for the day-to-day management of patient recruitment to research studies. To work on a daily basis with minimal supervision as part of a research team and in collaboration with the lead research GP. To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols. About us
The Practice is based within modern purpose-built premises hosting a variety of community services including District Nurses, Cardiology, Physiotherapy, and X-ray department. Part of Brighter Birkenhead Primary Care Network. High QOF achievers, and CQC Good in all areas. Training Practice with Doctors in Training / Medical Students. Supportive Practice with informal daily meetings facilitating peer support / case review etc. Job responsibilities
To maintain a high standard of patient care in line with local R and D policies and protocols and in accordance with the Research Governance Framework. To ensure that all data is collected and managed effectively and accurately and within timelines. To contribute to all aspects of the planning, conduct, and reporting of all clinical trials within the research specialty. Knowledge of clinical research would be an advantage but not essential as training and support will be provided. Some knowledge of ethics, law, drug development, and management in clinical issues would be advantageous. Partly responsible for submissions to research ethics committees. Maintaining overall standard of care for patients at all times. Educational and developmental role. Ability to give advice on the organisation and management of research in progress. Liaison with sponsor companies and multi-disciplinary research teams. Support the Patient Carer Public Involvement & Engagement strategy / ambassador for PCPIE. Key responsibilities
To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation. To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent. To assist the clinicians to report and record any adverse events as dictated by protocol and local protocols. To assist the clinicians with protocol development and ethical approval. To assist in the analysis of data and preparation of reports for presentation and publication. To co-ordinate and carry out patient visits in accordance with study protocols, including co-ordinating special tests in other departments, collection of data, coding, data entry, and patient support. To carry out consent, treatment procedures, and treatment interventions according to pre-determined protocols, including venepuncture, venous cannulation, administering of intra-venous drugs, and vital sign recording. To report on a regular basis to the Research Nurse Matron/ARDM and other Senior Research Nurse staff across base sites for professional support and guidance. To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols. To maintain a high standard of patient care in line with practice policies and protocols and in accordance with the Research Governance Framework. To ensure that all data is collected and managed accurately. To carry out the collection, processing, and shipping of biological specimens according to protocol requirements and follow up appropriately on alert values. To be involved in the education of patients and their various aspects of their disease. To ensure that patient safety is paramount in all procedures that take place for trial purposes. To ensure clinical and research documentation and record keeping is completed accurately and efficiently in accordance with the EU Directive, ICH GCP Guidelines. To work within the N.M.C Code of Conduct and scope of professional conduct. To have sufficient computer skills for the handling and management of computerized data. To keep up to date with relevant medical literature, developments in clinical research methodology, monitoring, and local regulatory and ethical requirements. To attend research network meetings, attend courses, conferences, and study days in order to remain up to date with all relevant aspects of clinical research. To participate in the education and development of staff/students, e.g. clinical supervision and ensure that all personnel are adequately informed about, and comply with all details of the trials. Person Specification
Qualifications
Registered Nurse Educated to Degree level Experience
Experience of working in Research and of conducting a research project. Experience of working in a Primary Care environment. Experience of Research management systems. Experience of working autonomously. 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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