Job summary
This post is a part time (30 hours per week) fixed term 21-months contract.
As a Clinical Trials Lead Nurse, you will provide operational leadership for the delivery of high-quality clinical trials within the organisation. You will ensure that clinical trials are conducted safely, ethically, and in accordance with regulatory, governance, and Good Clinical Practice standards. This is a critical role to R&D in the Trust and will build on the solid foundations already established within the research infrastructure at CPFT.
The post holder will be based in one of our R&D bases in the Trust, either at the Windsor Research Unit in Fulbourn Hospital or the Cavell Centre in Peterborough. They will be expected to travel between sites and to others relevant to the role events.
Please note for this role you will need the ability to travel independently and in a timely manner across Cambridgeshire and Peterborough to meet strict time deadlines.
Main duties of the job
You will provide line management, peer support, training, supervision, and play a key role in developing of the skills and knowledge of the R&D research delivery workforce. You will ensuring robust processes to support the study setup efficiencies, participant experience, intervention delivery, and follow-up across a portfolio of studies.
You will be working collaboratively with multidisciplinary teams, sponsors, investigators, and external partners; drive excellence in research delivery, promote a culture of evidence-based practice, and enhance opportunities for patients to participate in clinical trials. The role is central to improving trial performance, expanding research capacity, and ensuring patients have equitable access to clinical trial opportunities.
You will work in close partnership with the Research Delivery Lead to determine service priorities and coordinate effective workforce allocation.
This role plays a key part in achieving national performance metrics by ensuring high-quality, timely, and efficient delivery of the clinical trials research portfolio, contributing directly to the CPFT performance against national research delivery standards.
About us
Cambridgeshire and Peterborough NHS Foundation Trust is a health and social care organisation dedicated to providing high-quality care with compassion to improve the health and wellbeing of the people we care for, as well as supporting andempowering them to lead a fulfilling life.
Our clinical teams deliver many NHS services, not only via inpatient and primary care settings, but also within the community. These services include children's, adult and older people's mental health, forensic and specialist mental health, learning disabilities, primary care and liaison psychiatry, substance misuse, social care, research and development.
To achieve our goal, we look to recruit high-calibre candidates who share our vision and values. As an equal opportunities employer, we encourage applications from all sectors of the community, particularly from under-represented groups including people with long term conditions and members of our ethnic minority and LGBTQ+ communities.
Please be advised we reserve the right to close adverts earlier than the closing date should we receive sufficient applications.
Regrettably, we cannot offer sponsorship for all our job roles. If you apply for a role that we cannot offer sponsorship for, unfortunately, your application form will be rejected from the process.
For further information on CPFT, please visit our website at www.cpft.nhs.uk
Job description
Job responsibilities
Please refer to the attached job description and person specification for full details of responsibilities.
Oversee the setup, conduct, and closedown of clinical trials, ensuring compliance with protocols and regulatory standards.
Support feasibility assessments and capacity planning for new studies.
Ensure robust processes for screening, recruitment, informed consent, intervention delivery, and followup.
Provide expert clinical input into complex or highrisk studies.
Ensure accurate, timely data collection and documentation in line with GCP.
Monitor trial performance metrics and implement improvement actions where required.
Work collaboratively with R&D finance teams and sponsors to raise timely and accurate invoices for research activities, proactively resolving discrepancies and supporting robust financial governance across the research portfolio
Ensure adherence to GCP, UK Policy Framework for Health & Social Care Research, MHRA regulations, and local governance policies.
Lead internal audits, quality checks, and readiness for external inspections.
Maintain accurate essential documentation and trial master files/site files.
Develop and implement standard operating procedures (SOPs) for research delivery.
Support incident investigations and implement learning outcomes.
Ensure patient safety is prioritised throughout all research activities.
Provide advanced clinical assessment and decisionmaking for research participants.
Support the management and reporting of adverse events and protocol deviations.
Job description
Job responsibilities
Please refer to the attached job description and person specification for full details of responsibilities.
Oversee the setup, conduct, and closedown of clinical trials, ensuring compliance with protocols and regulatory standards.
Support feasibility assessments and capacity planning for new studies.
Ensure robust processes for screening, recruitment, informed consent, intervention delivery, and followup.
Provide expert clinical input into complex or highrisk studies.
Ensure accurate, timely data collection and documentation in line with GCP.
Monitor trial performance metrics and implement improvement actions where required.
Work collaboratively with R&D finance teams and sponsors to raise timely and accurate invoices for research activities, proactively resolving discrepancies and supporting robust financial governance across the research portfolio
Ensure adherence to GCP, UK Policy Framework for Health & Social Care Research, MHRA regulations, and local governance policies.
Lead internal audits, quality checks, and readiness for external inspections.
Maintain accurate essential documentation and trial master files/site files.
Develop and implement standard operating procedures (SOPs) for research delivery.
Support incident investigations and implement learning outcomes.
Ensure patient safety is prioritised throughout all research activities.
Provide advanced clinical assessment and decisionmaking for research participants.
Support the management and reporting of adverse events and protocol deviations.
Person Specification
Education / Qualifications
Essential
- Registered Nurse with current NMC registration
- ICH GCP
- Evidence of continuing professional development
- Leadership / Management training/qualification
Desirable
- Advanced Nurse Practitioner or Nurse Prescriber
- Project Management training or equivalent experience
Experience
Essential
- Substantial experience of working in a clinical research environment, i.e. Research Nursing, CRO or similar role.
- Experience of running concurrent research studies with minimal supervision according to GCP guidelines, in specialties: mental and physical health, dementia, rare diseases and learning disabilities.
- Experience in critically reviewing clinical trial protocols to assess feasibility, operational requirements, participant safety considerations, and alignment with organisational capacity.
- Experience in working with study sponsors, contract research organisations (CROs), and external vendors
- Experience in LPMS (EDGE), CPMS, ODP, SystmOne.
- Experience of accurate tracking of study activity, resource use, and cost recovery.
Desirable
- Experience of working with children and young people
- Experience working with various EDC systems
Knowledge & Skills
Essential
- In-depth knowledge of GCP, research governance, and regulatory frameworks.
- Ability to manage complex trials and competing priorities.
- Competence in clinical assessment and management of research participants.
- Good working knowledge of NIHR tariff, NCVR and iCT
Other
Desirable
- Ability to travel independently and in a timely manner across Cambridgeshire and Peterborough to meet strict deadlines.
Person Specification
Education / Qualifications
Essential
- Registered Nurse with current NMC registration
- ICH GCP
- Evidence of continuing professional development
- Leadership / Management training/qualification
Desirable
- Advanced Nurse Practitioner or Nurse Prescriber
- Project Management training or equivalent experience
Experience
Essential
- Substantial experience of working in a clinical research environment, i.e. Research Nursing, CRO or similar role.
- Experience of running concurrent research studies with minimal supervision according to GCP guidelines, in specialties: mental and physical health, dementia, rare diseases and learning disabilities.
- Experience in critically reviewing clinical trial protocols to assess feasibility, operational requirements, participant safety considerations, and alignment with organisational capacity.
- Experience in working with study sponsors, contract research organisations (CROs), and external vendors
- Experience in LPMS (EDGE), CPMS, ODP, SystmOne.
- Experience of accurate tracking of study activity, resource use, and cost recovery.
Desirable
- Experience of working with children and young people
- Experience working with various EDC systems
Knowledge & Skills
Essential
- In-depth knowledge of GCP, research governance, and regulatory frameworks.
- Ability to manage complex trials and competing priorities.
- Competence in clinical assessment and management of research participants.
- Good working knowledge of NIHR tariff, NCVR and iCT
Other
Desirable
- Ability to travel independently and in a timely manner across Cambridgeshire and Peterborough to meet strict deadlines.
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
Cambridgeshire and Peterborough NHS Foundation Trust
Address
Windsor Research Unit, Fulbourn Hospital
Cambridge Road
Fulbourn
CB215EF
Employer's website
https://www.cpft.nhs.uk/ (Opens in a new tab)
