Job summary
An exciting opportunity has arisen within the Cambridge Clinical Research Centre for a Vaccine Team Research Lead. You will work closely with the CCRC Vaccine Trial Team, Matrons and Team Leaders and be responsible for the delivery, management and oversight of all Vaccine studies across the CCRC with variety of specialties including: Neurosciences, Oncology, Haematology, Metabolic, Paediatric and Maternal Health. The role includes supporting / having oversight of Phase I applications for Vaccine Trials across CCRC & HLRI-CRF and other Phase I trials that CCRC Trial Team are providing coordination, and those assessed as High Risk using the new framework.
You will ensure that vaccine research undertaken within CCRC safeguards the well-being of participants and is conducted according to current regulatory requirements (Good Clinical Practice (GCP), Clinical Trial Regulations, Research Governance, GDPR and Trust local standard operating procedures (SOPs).
We are looking for an innovative and experienced individual as this role demands a high level of clinical and management skills.
This post involves shift patterns, including internal rotation onto night duty to ensure 24 hour cover (including bank holidays if needed).
Informal visits are encouraged. Please contact Viv Mendoza,vivien.mendoza@nhs.netor 01223 256754
Main duties of the job
Manage and coordinate all current and future Vaccine Studies in the CCRC
Ensure the safe administration of trial drugs, have in-depth knowledge of the legal requirements of a clinical trial sponsor regarding pharmacovigilance
Liaise with the Senior Team to ensure Trust approval is in place before the study commences
Write any local SOP's and or risk assessments required for each study
The post holder is responsible for the provision of high quality, patient focused clinical research for the NIHR CRF/Cambridge Clinical Research Centre
Work collaboratively with CCRC Education and Training Leads to ensure team has skills, knowledge and competence to deliver vaccine trials. Facilitate research/evidence passed practice and support research projects
Work collaboratively with the CCRC Team Leaders to ensure vaccine studies are undertaken to a high standard
Act as a point of contact for vaccine studies within the CCRC Vaccine Team
Work closely with PIs to prepare study applications (e.g. core documents, risk assessments, costs) for CCRC Scientific Advisory Board (SAB), present Vaccine Trial applications to SAB and action any recommendations prior to trial starting. Implement studies within an appropriate timeframe
Maintain CCRC Vaccine Trial database, provide updates to Directors
Attend CCRC Team Leader meetings, CRN & Cambridge Vaccine Hub meetings, CCRC Vaccine Team Meetings and any other relevant forum
About us
Come Nurse with us...
Cambridge University Hospitals NHS Foundation Trust is one of the largest teaching Trusts in the country. It comprises Addenbrooke's Hospital and the Rosie Hospital. We provide accessible high-quality healthcare for the local people of Cambridge and regional and national specialist services. It's a great place to nurse, work and live.
You will work on a vibrant hospital campus with a friendly community feel; we have excellent facilities to practice your skills and abilities to support your career pathway and development. Our values of Together - Safe, Kind, Excellent support the delivery of outstanding care. We have a fully electronic patient record system that is improving health-care quality; this is transforming services, improving patient safety and clinical outcomes.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Closing date is midnight on 25 January 2024
Interviews are due to be held on 7 February 2024
Why choose Cambridge University Hospitals?
- Our values and reputation for outstanding care
- Opportunities to experience a range of specialities
- Career and development opportunities
- Preceptorship and mentoring programmes delivered by a dedicated clinical education support team
- Research experience and opportunities
- Lovely location and quality of life
- Excellent schools/colleges and transport links (road, rail and air)
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Closing date is midnight on 25 January 2024
Interviews are due to be held on 7 February 2024
Why choose Cambridge University Hospitals?
- Our values and reputation for outstanding care
- Opportunities to experience a range of specialities
- Career and development opportunities
- Preceptorship and mentoring programmes delivered by a dedicated clinical education support team
- Research experience and opportunities
- Lovely location and quality of life
- Excellent schools/colleges and transport links (road, rail and air)
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- NMC level 1 registration
- Current mentor
- Current ILS certificate holder
- Current ICH/GCP training
- Evidence of on-going professional development
Desirable
- First Degree or studying towards First Degree
- Research module / certificate
- Management / Leadership Training
Experience
Essential
- Considerable Band 6 or above experience in early phase clinical research trial delivery
- Experience of delivering / managing vaccine trials in fast recruiting / high participant volume trials
- Experience in managing trials with frequent changes / amendments
- Working with Industry (Sponsors, Monitors, eCRFs)
- Use of Electronic case report forms, data entry & managing data queries
Desirable
- Writing standard operating procedures
- Risk assessment & inspection
- Phase I first in human trial delivery
- Working in a Clinical Research Facility
- Line management experience
Knowledge
Essential
- Evidence of leadership qualities/skills
- Effective Resource Management regulatory requirements (Research Governance, GCP, GDPR, Directives)
Desirable
- National Institute for Health Research
- Current research nursing issues
- R&D in NHS
Skills
Essential
- Ability to interpret patient records and extract data accurately
- Teaching and Presentation Skills
- Assertiveness skills
- Effective change management skills
- Team motivation skills and effective team worker
- Excellent written/oral communication skills
- Able to keep accurate/detailed records
- Able to plan, implement and evaluate care for a patients having novel therapeutic interventions
- Advanced clinical competence in venepuncture, cannulation, IV infusions & related equipment
Desirable
- IT skills
- Project Management
- Skilled in managing diverse multi-disciplinary groups.
- Sample processing/centrifuging
Additional Requirements
Essential
- Well motivated, positive role model
- Able to work a range of shifts: nights & weekends
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
Person Specification
Qualifications
Essential
- NMC level 1 registration
- Current mentor
- Current ILS certificate holder
- Current ICH/GCP training
- Evidence of on-going professional development
Desirable
- First Degree or studying towards First Degree
- Research module / certificate
- Management / Leadership Training
Experience
Essential
- Considerable Band 6 or above experience in early phase clinical research trial delivery
- Experience of delivering / managing vaccine trials in fast recruiting / high participant volume trials
- Experience in managing trials with frequent changes / amendments
- Working with Industry (Sponsors, Monitors, eCRFs)
- Use of Electronic case report forms, data entry & managing data queries
Desirable
- Writing standard operating procedures
- Risk assessment & inspection
- Phase I first in human trial delivery
- Working in a Clinical Research Facility
- Line management experience
Knowledge
Essential
- Evidence of leadership qualities/skills
- Effective Resource Management regulatory requirements (Research Governance, GCP, GDPR, Directives)
Desirable
- National Institute for Health Research
- Current research nursing issues
- R&D in NHS
Skills
Essential
- Ability to interpret patient records and extract data accurately
- Teaching and Presentation Skills
- Assertiveness skills
- Effective change management skills
- Team motivation skills and effective team worker
- Excellent written/oral communication skills
- Able to keep accurate/detailed records
- Able to plan, implement and evaluate care for a patients having novel therapeutic interventions
- Advanced clinical competence in venepuncture, cannulation, IV infusions & related equipment
Desirable
- IT skills
- Project Management
- Skilled in managing diverse multi-disciplinary groups.
- Sample processing/centrifuging
Additional Requirements
Essential
- Well motivated, positive role model
- Able to work a range of shifts: nights & weekends
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Employer details
Employer name
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital-Division R&D
Keith Road
Cambridge
CB2 0SL
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)