Job responsibilities
Job summary
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.
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 speciality
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/ARDMand other and 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 computerised 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.
