Senior Research Nurse

Unit Management Manage a designated number of research studies Maintain a safe environment, for patients, staff and visitors, ensuring that all control measures comply with NGH current policies and procedures, and any statutory requirements, including all Health and Safety and Clinical Governance arrangements Use judgement in relation to competing demands for funding, staff and teamresources Contribute to the control of the research unit budget ensuring that adequatemeasures exist for delivery of the research studies Respond to change in line with the needs of service provision Responsible for the development and updating of teams policies and procedures Ensure that all record keeping within the department is appropriate, timely and clearly understood for the purpose of patient care, safety and data integrity Education • Identify own learning needs and proactively seek educational opportunities to fulfil them • Develop skills in accordance with the NIHR CRN Competency Framework for research delivery staff appropriate to the Band 6 role Strategic Role Be a champion of clinical research Support and influence the embedding of clinical research within the Trust Foster good relationships with key division research leads / support departments /Institutes and partners to promote the efficient running of clinical trials and develop the Trust research portfolio Contribute to the development and updating of research policies and procedures within NGH Take an active role in the activities of professional forums and networks Disseminate the results of research into clinical nursing practice Staff Management Maintain standards of practice in accordance with the legal rules and statutory regulations set out by the NMC or appropriate professional body Support the professional and educational development of research teams nursing,allied health professional and administrative staff, assisting in identifying needs and finding solutions Support the training and ensure the appropriate supervision of research teams staff, contributing to their mentorship and monitoring Line manage research nurses and A&C staff within the team as and when agreed Assist with the recruitment, selection, induction and orientation for new research nursing, allied health professional and administrative staff Facilitate the team working effectively and cohesively together, developing the relevant clinical skills, delivering studies to time and target Provide day to day management of the research team in the absence of the Clinical Research Managers, ensuring all staff and activities comply with trust policies and guidelines To act as a role model in establishing good practice and establishing standards of care and management that should be adhered to 24hrs a day Responsible for effective communication within the nursing teams ensuring that all members are well briefed on key departmental and corporate issues Promote an approach to patients focussed on care and compassion, ensuring courtesy and respect at all times Ensure that standard operating procedures are followed by all members of the research team Instigate and oversee Quality Improvement projects in Research & Innovation Study Set Up Ensure all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation Signpost to advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory and trust approval. Have a detailed knowledge and understanding of research design and methodology Contribute to the assessment of study protocols and advise on any safety, regulatory and logistical issues Provide oversight for the set-up of a designated number of research studies within the team, acting as point of contact for R&I in the feasibility process Project manage study set up with colleagues from around the Trust (support departments, finance etc.) and within the University of Northampton Study Conduct Support local Principal Investigators in meeting their responsibilities outlined in regulatory and legal frameworks Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations. Identify & screen appropriate study participants, in accordance with the protocol, & in conjunction with other members of the clinical & research teams Receive informed consent for designated research studies as agreed within the protocol Provide knowledge and demonstrate accurate attention to detail in documentationtasks, to include: o Investigator Site File maintenance o CRF completion o Documenting source data Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the division and wider UHN research community as appropriate. Act as a resource to PIs in ensuring all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP, ISO 14155 and UHN Adverse Events Reporting policy Where appropriate, liaise with the R&I department in identifying any barriers to recruitment and the running of the study; support the study team in developing strategies to mitigate them Support the study team in ensuring all reporting to regulatory bodies, R&I and Research Networks (if applicable) is completed in a timely manner Support the study team to ensure that all equipment used is appropriately checked and calibrated with supporting documentation retained Liaise with Sponsors to ensure all arrangements for research governance for each study are in place Study End Ensure all data clarification issues are resolved quickly Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations/ISO 14155 as appropriate. Where appropriate, ensure a smooth transition from the research pathway back to the conventional treatment pathway Job description Job responsibilities Unit Management Manage a designated number of research studies Maintain a safe environment, for patients, staff and visitors, ensuring that all control measures comply with NGH current policies and procedures, and any statutory requirements, including all Health and Safety and Clinical Governance arrangements Use judgement in relation to competing demands for funding, staff and teamresources Contribute to the control of the research unit budget ensuring that adequatemeasures exist for delivery of the research studies Respond to change in line with the needs of service provision Responsible for the development and updating of teams policies and procedures Ensure that all record keeping within the department is appropriate, timely and clearly understood for the purpose of patient care, safety and data integrity Education • Identify own learning needs and proactively seek educational opportunities to fulfil them • Develop skills in accordance with the NIHR CRN Competency Framework for research delivery staff appropriate to the Band 6 role Strategic Role Be a champion of clinical research Support and influence the embedding of clinical research within the Trust Foster good relationships with key division research leads / support departments /Institutes and partners to promote the efficient running of clinical trials and develop the Trust research portfolio Contribute to the development and updating of research policies and procedures within NGH Take an active role in the activities of professional forums and networks Disseminate the results of research into clinical nursing practice Staff Management Maintain standards of practice in accordance with the legal rules and statutory regulations set out by the NMC or appropriate professional body Support the professional and educational development of research teams nursing,allied health professional and administrative staff, assisting in identifying needs and finding solutions Support the training and ensure the appropriate supervision of research teams staff, contributing to their mentorship and monitoring Line manage research nurses and A&C staff within the team as and when agreed Assist with the recruitment, selection, induction and orientation for new research nursing, allied health professional and administrative staff Facilitate the team working effectively and cohesively together, developing the relevant clinical skills, delivering studies to time and target Provide day to day management of the research team in the absence of the Clinical Research Managers, ensuring all staff and activities comply with trust policies and guidelines To act as a role model in establishing good practice and establishing standards of care and management that should be adhered to 24hrs a day Responsible for effective communication within the nursing teams ensuring that all members are well briefed on key departmental and corporate issues Promote an approach to patients focussed on care and compassion, ensuring courtesy and respect at all times Ensure that standard operating procedures are followed by all members of the research team Instigate and oversee Quality Improvement projects in Research & Innovation Study Set Up Ensure all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation Signpost to advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory and trust approval. Have a detailed knowledge and understanding of research design and methodology Contribute to the assessment of study protocols and advise on any safety, regulatory and logistical issues Provide oversight for the set-up of a designated number of research studies within the team, acting as point of contact for R&I in the feasibility process Project manage study set up with colleagues from around the Trust (support departments, finance etc.) and within the University of Northampton Study Conduct Support local Principal Investigators in meeting their responsibilities outlined in regulatory and legal frameworks Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations. Identify & screen appropriate study participants, in accordance with the protocol, & in conjunction with other members of the clinical & research teams Receive informed consent for designated research studies as agreed within the protocol Provide knowledge and demonstrate accurate attention to detail in documentationtasks, to include: o Investigator Site File maintenance o CRF completion o Documenting source data Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the division and wider UHN research community as appropriate. Act as a resource to PIs in ensuring all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP, ISO 14155 and UHN Adverse Events Reporting policy Where appropriate, liaise with the R&I department in identifying any barriers to recruitment and the running of the study; support the study team in developing strategies to mitigate them Support the study team in ensuring all reporting to regulatory bodies, R&I and Research Networks (if applicable) is completed in a timely manner Support the study team to ensure that all equipment used is appropriately checked and calibrated with supporting documentation retained Liaise with Sponsors to ensure all arrangements for research governance for each study are in place Study End Ensure all data clarification issues are resolved quickly Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations/ISO 14155 as appropriate. Where appropriate, ensure a smooth transition from the research pathway back to the conventional treatment pathway