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Detailed job description and main responsibilities

PRINCIPAL ACCOUNTABILITIES

Lead and Supervise all aspects of study initiation for clinical trials for the Trust.

Comprehensive knowledge of clinical research including issues on ethics, law, drug development and management in clinical trials

Accountable for the nursing and of research projects

Responsible for submissions to research ethics committees

Advising specialists in the field on the application of research

Dissemination and publication of research findings

Maintaining overall standard of care for patients at all times

Liaison with sponsor companies and multidisciplinary research teams

Ability to give advice on the organisation and management of the research in progress

Good project Management skills

To contribute to all aspects of the planning, conduct and reporting of all clinical trials and in-house studies

Plan and implement duty roster for the team of Research Nurses

Engage in and find workable solutions to systems troubleshooting

Provide coordination and direction in the development of data management methodologies and standard operating procedures (SOPS)

Monitor data completion and data quality for clinical trials

Evaluate and review high level study reports to confirm accuracy in data reporting for data monitoring and study committees

Develop and monitor study timelines and key deliverables in clinical trials in collaboration with internal and external stakeholders

Prepare and present written reports for presentation at relevant Trust committees including research and innovation committee and divisional governance committees.

Attend update calls and respond to inquiry emails for site reporting and to support requests for clinical trials.

Support Principal Investigators in all aspects for clinical trial delivery

To be responsible for the day-to-day management of, and patient recruitment to, all studies within the speciality.

To work on a daily basis with minimum supervision as part of the research team

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 Trust and R&D polices and protocols in accordance to the UK Policy Framework for Health and Social Care Research

To priorities research activity as necessary thus ensuring recruitment targets are met

To ensure that all data is collected and manged effectively and accurately

To co-ordinate all designated clinical research studies as directed by the lead clinician to ensure recruitment targets are met.

To initiate, organise and manage novel clinical research and audit projects within the speciality (retrospective and prospective) under the supervision of the lead consultant, including where appropriate, negotiation of research funding, development of protocols, ethical committee application, data presentation at meetings, recruitment, questionnaire completion, clinical measurement, statistical analysis and preparation of papers for publication.

To identify, screen, interview patients and recruit them into the appropriate studies.

To assist with informed consent process, ensuring the patient is fully informed prior to participation in the study.

To report and record any adverse events as dictated by Trust and Departmental Protocols

To ensure clinical and research documentation and record keeping is completed accurately and efficiently in accordance with HRA NMC and EU Directive (ICH-GCP) guidelines

To report to the Head of R&I for support

To lead and support other Specialist Nurses within the speciality

To work closely with the Head of Research Governance

To keep up to date with relevant medical literature, developments in clinical research methodology, monitoring and local regulatory and ethical requirements  

To attend courses, conferences and study days in order to remain up to date with all relevant aspects of clinical research

To attend relevant research meetings such as the Research and Innovation Committee

To assist in the analysis of data and preparation of reports for presentation and publication

To understand the relevance of research to health care delivery and be able to identify research problems within the speciality

To develop the skills of other staff by identifying needs through observation and ensuring participation, practice and relevant education.

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.