Job summary
The Research and Development team are seeking a Team Leader for the Clinical Research Facility (St. Stephen's Centre, Chelsea & Westminster Hospital). We are looking for a dynamic individual who has a combination of clinical research and leadership experience.
This would be an excellent opportunity for an experienced research nurse who is motivated and enthusiastic to join a friendly, driven team as we continue to develop our Clinical Research Facility portfolio, which includes Phase 1, 2 and 3 studies (Commercial, NIHR and Investigator Initiated Awards). Experience in the field of HIV and infectious diseases an advantage but not essential. The successful candidate will be fully supported by both colleagues in the CRF and in the wider research team.
Main duties of the job
The Clinical Research Team Leader will support the aims of the Trust Research Strategy by facilitating the delivery of high quality research in the CRF and outlying sexual health clinics and will be a recognised expert in the field of clinical research, including phase I and 2 trials.
The post holder will ensure that any research undertaken safeguards the well-being of research participants and is conducted in accordance with ICH Good Clinical Practice. He/she will provide expert support to colleagues throughout the research study process, from leading feasibility and site qualification visits for new studies to managing clinical pathways and study delivery, and will have extensive experience in all aspects of commercially funded research. Additionally, the role involves numerous management and leadership duties, including recruitment and retention, training, and mentoring.
The selected candidate will act as team leader for several team members and will be responsible for annual PDRs, annual leave, and sickness management, as well as serving as the nurse in charge on a daily basis. This will include organising study visits for the day, managing staff, and being heavily involved in the delivery of studies from recruitment to close-out visits, assisting in clinics, and performing clinical tasks.
Furthermore, he/she will work collaboratively and act as an expert resource for colleagues, participants, and patients to ensure the smooth running of visits.
About us
Chelsea and Westminster Hospital NHS Foundation Trust is proud to be one of the top performing and safest trusts in England. We have two main acute hospital sites--Chelsea and Westminster Hospital and West Middlesex University Hospital, plus our award-winning clinics across North West London and beyond.
Job description
Job responsibilities
Clinical & Research
- To facilitate efficient, safe and participant focused research including screening procedures, biological sample collection, and all clinical observations required to ensure and maintain patient safety before, during and after the research visit.
- To take responsibility for ensuring patient facing equipment is maintained in line with Trust policy
- To ensure all research staff (registered and unregistered) practice safely according to Trust policy, including the facilitation and recording of all mandatory and specific study related training.
- To ensure biological samples are kept according to GCP and Trust standards.
- To review new studies and work with the CRF Clinical Lead and manager on initial study feasibility.
- To lead on the set up, coordination and management of the CRF portfolio of clinical research studies
- Demonstrate sound knowledge of the life cycle of a research project from inception to study close out and performing all clinical protocol related tasks independently to include
- Provide comprehensive advice and guidance on matters relating to research ethics and governance
- Take an active role in contributing to local recruitment strategies, identifying required workforce and skill mix to deliver local portfolio
- Ensure Good Clinical Practice and research governance standards for clinical research are adhered and maintained
- Act as an expert resource for staff, researchers and research participants, providing an in-depth knowledge of aspects pertinent to acquiring and maintaining informed consent.
- To facilitate the informed consent process and contributes to the monitoring of consent procedures
- Ensure the processes and procedures for participant confidentiality are developed and adhered to according to Trust policy.
- To be responsible for the delivery teams compliance of data ensuring study data is collated and transferred in a timely manner
- To identify barriers to recruitment and implement necessary action plan
- To act as a knowledgeable resource for staff and researchers on matters relating to clinical practice and research, promoting an active and effective research culture.
- To use specialist knowledge to manage the clinical research team, prioritising workload according to changing needs in line with local and national guidelines
- In conjunction with the Principle Investigator provide a suitable and safe environment for the physical and psychological well-being of staff, patients and their relatives
- To delegate tasks and activities to a range of team members in relation to ensuring safe planning and care of patient
- To recognise and act on concerns raised if research deviates from the study protocol or the study design conflicts with legal requirements
- Operational Management
- Provide professional and clinical leadership to the research teams
- To be a key player in the feasibility process of new studies in the CRF.
- To take a lead role in the study set up process, being aware of research costs and support the speedy set up of gaining local permission for research studies
- To lead on ensuring studies meet time and target, identifying barriers to recruitment and implementing and monitoring action plans
- To ensure research study costs are recorded in a timely manner and attributed to the appropriate cost centre
- To initiate and develop Standard Operating Procedures within your department
- To ensure effective communication systems are in place for staff and to facilitate timely information flows to internal and external stakeholders
- To ensure study records and trial files are maintained and kept up-to-date
- To ensure all clinical study documentation is presented accurately with localised headings and correct version numbers
- To ensure clinical study amendments are processed according to local policy
- To ensure the clinical research recruitment records are accurately maintained and research staff are informed of the progress in accordance with trust policy
- To ensure that clinical studies are effectively archived as required
- Leadership, Staff Management
- Provide research and clinical leadership across the whole spectrum of the research pathway
- Actively raise the profile of clinical research by educating clinical staff and patients about research
- To ensure all nursing staff are registered with the appropriate nursing body and all staff have the appropriate skills to undertake clinical research tasks
- To provide professional, supportive leadership with underpins the trusts values and behaviours
- To ensure and monitor adherence to the full range of trust policies and procedures
- To ensure all staff under your line management have annual personal and professional development review (PDR) according to local policy
- To lead on recruitment and retention initiatives and recruit new staff in line with local policy
- Monitor and support trust policies and procedures, i.e. sickness and absence, grievances and disciplinary
- Maintain your own personal and professional development keeping updated with current practice
- Lead in the education and support of health care professionals to enable them to care for research participants
- To maintain effective communication and working relationships with all internal and external research members
- Maintain an awareness of changes within the health service and the implications of these for clinical research
- Lead and attend team, local and national meetings as appropriate
- To support student nurses/midwives and AHPs on placement
Job description
Job responsibilities
Clinical & Research
- To facilitate efficient, safe and participant focused research including screening procedures, biological sample collection, and all clinical observations required to ensure and maintain patient safety before, during and after the research visit.
- To take responsibility for ensuring patient facing equipment is maintained in line with Trust policy
- To ensure all research staff (registered and unregistered) practice safely according to Trust policy, including the facilitation and recording of all mandatory and specific study related training.
- To ensure biological samples are kept according to GCP and Trust standards.
- To review new studies and work with the CRF Clinical Lead and manager on initial study feasibility.
- To lead on the set up, coordination and management of the CRF portfolio of clinical research studies
- Demonstrate sound knowledge of the life cycle of a research project from inception to study close out and performing all clinical protocol related tasks independently to include
- Provide comprehensive advice and guidance on matters relating to research ethics and governance
- Take an active role in contributing to local recruitment strategies, identifying required workforce and skill mix to deliver local portfolio
- Ensure Good Clinical Practice and research governance standards for clinical research are adhered and maintained
- Act as an expert resource for staff, researchers and research participants, providing an in-depth knowledge of aspects pertinent to acquiring and maintaining informed consent.
- To facilitate the informed consent process and contributes to the monitoring of consent procedures
- Ensure the processes and procedures for participant confidentiality are developed and adhered to according to Trust policy.
- To be responsible for the delivery teams compliance of data ensuring study data is collated and transferred in a timely manner
- To identify barriers to recruitment and implement necessary action plan
- To act as a knowledgeable resource for staff and researchers on matters relating to clinical practice and research, promoting an active and effective research culture.
- To use specialist knowledge to manage the clinical research team, prioritising workload according to changing needs in line with local and national guidelines
- In conjunction with the Principle Investigator provide a suitable and safe environment for the physical and psychological well-being of staff, patients and their relatives
- To delegate tasks and activities to a range of team members in relation to ensuring safe planning and care of patient
- To recognise and act on concerns raised if research deviates from the study protocol or the study design conflicts with legal requirements
- Operational Management
- Provide professional and clinical leadership to the research teams
- To be a key player in the feasibility process of new studies in the CRF.
- To take a lead role in the study set up process, being aware of research costs and support the speedy set up of gaining local permission for research studies
- To lead on ensuring studies meet time and target, identifying barriers to recruitment and implementing and monitoring action plans
- To ensure research study costs are recorded in a timely manner and attributed to the appropriate cost centre
- To initiate and develop Standard Operating Procedures within your department
- To ensure effective communication systems are in place for staff and to facilitate timely information flows to internal and external stakeholders
- To ensure study records and trial files are maintained and kept up-to-date
- To ensure all clinical study documentation is presented accurately with localised headings and correct version numbers
- To ensure clinical study amendments are processed according to local policy
- To ensure the clinical research recruitment records are accurately maintained and research staff are informed of the progress in accordance with trust policy
- To ensure that clinical studies are effectively archived as required
- Leadership, Staff Management
- Provide research and clinical leadership across the whole spectrum of the research pathway
- Actively raise the profile of clinical research by educating clinical staff and patients about research
- To ensure all nursing staff are registered with the appropriate nursing body and all staff have the appropriate skills to undertake clinical research tasks
- To provide professional, supportive leadership with underpins the trusts values and behaviours
- To ensure and monitor adherence to the full range of trust policies and procedures
- To ensure all staff under your line management have annual personal and professional development review (PDR) according to local policy
- To lead on recruitment and retention initiatives and recruit new staff in line with local policy
- Monitor and support trust policies and procedures, i.e. sickness and absence, grievances and disciplinary
- Maintain your own personal and professional development keeping updated with current practice
- Lead in the education and support of health care professionals to enable them to care for research participants
- To maintain effective communication and working relationships with all internal and external research members
- Maintain an awareness of changes within the health service and the implications of these for clinical research
- Lead and attend team, local and national meetings as appropriate
- To support student nurses/midwives and AHPs on placement
Person Specification
Education
Essential
- Health professional registration or first degree in life sciences
- Master's Degree or equivalent experience
- Teaching qualification or equivalent experience
- Evidence of on-going personal and professional development
Desirable
- Leadership training/education
Experience
Essential
- Experience of all aspects of clinical trials from selection to close out
- Extensive experience of leading on Phase 1 & 2 studies
- Current research nursing experience within a Clinical Research Facility at Band 6
- Understanding of the Research Governance Framework and ICH GCP
- Experience and understanding of change management and facilitation of these processes
- Experience of representing the team at internal and external meetings/forums
- Experience of supervision of junior staff and Human Resources process
Desirable
- Experience in the field of HIV and infectious diseases
Personal attributes
Essential
- Excellent communication skills
- Ability to problem solve and think creatively
- Demonstrates professionalism, commitment and an enthusiasm for change and growth
Person Specification
Education
Essential
- Health professional registration or first degree in life sciences
- Master's Degree or equivalent experience
- Teaching qualification or equivalent experience
- Evidence of on-going personal and professional development
Desirable
- Leadership training/education
Experience
Essential
- Experience of all aspects of clinical trials from selection to close out
- Extensive experience of leading on Phase 1 & 2 studies
- Current research nursing experience within a Clinical Research Facility at Band 6
- Understanding of the Research Governance Framework and ICH GCP
- Experience and understanding of change management and facilitation of these processes
- Experience of representing the team at internal and external meetings/forums
- Experience of supervision of junior staff and Human Resources process
Desirable
- Experience in the field of HIV and infectious diseases
Personal attributes
Essential
- Excellent communication skills
- Ability to problem solve and think creatively
- Demonstrates professionalism, commitment and an enthusiasm for change and growth
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).