SC
Skilled Worker, A ratingPosted 1 month ago

Job Description

Job summary

  • To contribute to all aspects of the planning, conduct and reporting of all primary care clinical research trials
  • 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.
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