Job summary
Band 5 Cardiac Research Practitioner (CRP)/ Cardiac Research Nurse
Applications are invited for an enthusiastic, motivated Clinical Research Practitioner (CRP) or Research Nurse to join the dynamic and world-renowned Cardiac Research Department at Northwick Park Hospital, London North West University Healthcare NHS Trust.
This is an exciting opportunity for someone new to clinical research or looking to develop their career from research administration into research delivery. We are looking for candidates with a genuine interest in building a career in clinical research. A commitment to improving outcomes for patients and working in a proactive and innovative team is essential.
This a new position within the team, offered as a one-year fixed-term contract in the first instance.
The successful candidate will be responsible for leading the coordination of a portfolio of clinical research studies, in cardiovascular conditions according to ICH-GCP guidelines. Responsible for all aspects of the research life cycle from conception, delivery through to close out: your main responsibilities will include recruitment of patients, delivering visit schedules and assessments to protocol and safe, accurate data collection and reporting.
Main duties of the job
The post holder will be responsible for the coordination of a portfolio of clinical trials in cardiovascular conditions according to GCP and ICH guidelines. Responsibilities will include recruitment of patients, coordination of visit schedules as directed by specific research protocols and thorough and accurate research data collection. The post holder will work as part of the research team or independently as required in the organisation of clinical trials or on Trust approved research projects. They will provide excellent and safety focused patient care at all times and will liaise effectively with other health care professionals to deliver a seamless professional service. The post holder would be expected to maintain a range of clinical and administrative skills to support clinical trial activity and to have up to date knowledge of both the care and treatment of cardiovascular conditions and of research procedures.
About us
London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.
Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.
We run major acute services at:
- Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK
- St Mark's Hospital: an internationally renowned specialist centre for bowel disease
- Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice
- Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre.
We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.
Job description
Job responsibilities
KEY RESPONSIBILITIES
- Key Working Relationships
- The multi-disciplinary cardiac research team
- Investigators
- Clinical staff
- Trust Research & Development Department
- Study Sponsors
- Study Vendors
- NIHR CRN North West London
- Clinical Trials Pharmacy Team
- Research and Clinical
- To facilitate safe, efficient, patient focussed research.
- To demonstrate sound knowledge of the life cycle of a research project from inception to study close out and perform all clinical protocol related tasks independently as a lead study coordinator on non-CTIMP research studies and working under supervision of more senior team members on CTIMP studies. Duties to include:
- Ensuring all site staff are trained, delegated and appropriate approvals are in place for studies.
- Patients are pre-screened, approached and recruited in a suitable way, having a detailed understanding of the informed consent process and clinical patient pathway.
- Planning of the schedule of events and study visits is taken to ensure the study is delivered safely and to protocol.
- Safely and accurately perform, record and capture administrative and clinical assessments in medical notes.
- Collect, store and transfer biological samples in accordance with study protocol, trust policies and safe shipping legal requirements.
- In an accurate and timely manner transfer source data to electronic case report forms (eCRFs) and respond to data queries.
- Monitoring of the patient within the study visit: be able to recognise and respond appropriately to deteriorating/ urgent/ emergency situations.
- Recoding and reporting of adverse events.
- Working under supervision of more senior team members, ensuring Investigation Medicinal Product procedures are performed according to staffs competency and scope of practice and to both Trust and Sponsor protocols.
- Maintaining the Investigator Site File and departmental shared drive to the highest standards.
- Maintain a suitable and in-date supply of study supplies e.g. as lab kits, needles.
- Providing Sponsors and Investigators with data and information as required and responding positively to requests.
- Coordinate and facilitate productive Sponsor, regulatory and R&D monitoring visits and responding to action items in a timely manner.
- To work according to ICH-GCP and research governance standards for clinical research studies.
- To be competent in a range of clinical skills required for research studies and be willing to undertake training for new skills.
- To be competent in a range of IT and administrative skills required for clinical research and be willing to undertake training for new skills.
- To be fully trained and competent in all aspects of study medication storage, transport and administration (within scope of practice, depending on type of professional registration): adhering to all requirements of the Clinical Trials Pharmacy Team.
- To ensure accurate and comprehensive medical and research records are maintained using appropriate documentation.
- To recognise and act on concerns raised if research deviates from the study protocol or the study design conflicts with legal or patient safety requirements.
- To identify barriers to recruitment and implement agreed action plans as required.
- To manage own caseload of non-CTIMP clinical research studies, working collaboratively with wider multidisciplinary teams.
- To be trained and delegated on all departmental research studies to provide cover for any staff absence.
- To provide thorough verbal and written handover of own workload prior to any planned leave.
- Attend meetings relevant to the clinical and research area and disseminate information to colleagues.
- To act as a knowledgeable resource in clinical practice and research, promoting an active and effective research culture.
- To ensure all departmental equipment is calibrated and maintained according to study and Trust requirements and calibration certificates are appropriate shared with Sponsors.
- To respond to patients and carers/family members in a timely, respectful and considerate manner.
- Act as advocate for patients to enable them to make informed decisions regarding study participation. There may be barriers to understanding complex clinical trials.
- Within own scope of practice and expertise, exercise professional autonomy and critical judgement when assessing patients in clinical follow up visits and when giving advice to patients on the telephone. To recognise limitations of own scope of practice and seek the support and expertise of more senior colleagues as required.
- Deliver health education within research visits and provide advice to patient, family and other members of the team.
- To liaise and communicate effectively any changes to patient care with other members of the clinical team and outside agencies as required.
- To liaise with Ward Pharmacists, Clinical Teams and Clinical Trials Pharmacy when clinical trial patients are hospitalised to ensure patient safety as prescribed drugs for hospitalisations may interact with clinical trial medication.
- Responsible for accurately entering details of patients and their treatment into clinical computer based and paper-based systems.
- Communicate with research team and/or research admin staff to ensure timely ordering of necessary stocks.
- Administration
- To work at all times in a methodical manner, with a high attention to detail.
- To manage running of own allocated clinical research studies on a day to day basis, which requires coordination with the wider team, other healthcare professionals in the multi-disciplinary team and outside agencies. To provide support and work under supervision of more senior colleagues on CTIMP studies running within the department.
- To be an expert for assigned clinical trials and to ensure the promotion and delivery of high standards of clinical care and clinical practice.
- Able to prioritize workload, delegate where appropriate and alert manager when help is required.
- Able to plan own workload in accordance with trial specific protocol and schedule of assessments.
- To promote effective working relationships between all members of staff to develop professionalism throughout the department.
- To be able to problem-solve communication barriers and act appropriately.
- Adhere to Trust policies pertaining to patient confidentiality/ GDPR /Caldicott Recommendations.
- Reimbursing patient travel expenses, providing patient refreshments and booking patient taxis.
- Education and Training
- To act in accordance with the NMC Code of Professional Conduct for Nurses, Midwives and Health Visitors and to be always accountable for own clinical practice and professional actions (Nurses only).
- To ensure continued registration with the NMC (Nurses only).
- To act in accordance with the NIHR/AHCS Standards of Proficiency for CRPs and Scope of Practice for CRPs (CRPs only)
- To be accredited or working towards accreditation on the AHCS Accredited Register for CRPs and to maintain continued registration (CRPs only)
- To participate in departmental reflection sessions between CRPs and Research Nurses as part of ongoing professional revalidation processes and to support ongoing learning and personal insight.
- To develop and maintain knowledge of cardiovascular conditions, treatments, and investigations.
- To ensure ongoing compliance with mandatory training.
- To maintain regular Good Clinical Practice training as required.
- To undertake clinical and research competencies as required.
- To undertake annual trust appraisal process to support personal and professional development.
- To support and supervise in the induction, training and ongoing development of junior staff, newly recruited staff and work experience students in the department.
- To support in the training and education of other healthcare professionals working on research studies.
- To identify and attend relevant external and local training which contributes to ongoing personal and professional development.
- To attend study training, investigator meetings and conferences as required.
- Participate significantly towards research department improvement projects, setting standards, audits and monitoring quality within the area of clinical research.
- Department Specific Requirements
- To prioritise patient safety at all times.
- To treat all research patients and their families/carers with the greatest respect and consideration, going above and beyond to ensure they have a positive experience of participating in clinical research, supporting retention in all research studies.
- To work flexibly outside of usual hours where required to meet patient, study or department needs.
- Willingness to deliver research studies in areas outside of the immediate department e.g. A&E.
- To contribute to the development of departmental policies and SOPs, adhering to these and those of the Trust at all times.
- To ensure that the Cardiac Research Department complies with ethical, regulatory, legal, Trust and R&D standards at all times.
- To attend investigator meetings, which may be international, when required.
- General
- Frequent and prolonged sitting at computer terminal.
- Travel long distances to departments and wards with which face-to-face liaison occurs (such as A&E and R &D) which are not in close proximity to the department.
Job description
Job responsibilities
KEY RESPONSIBILITIES
- Key Working Relationships
- The multi-disciplinary cardiac research team
- Investigators
- Clinical staff
- Trust Research & Development Department
- Study Sponsors
- Study Vendors
- NIHR CRN North West London
- Clinical Trials Pharmacy Team
- Research and Clinical
- To facilitate safe, efficient, patient focussed research.
- To demonstrate sound knowledge of the life cycle of a research project from inception to study close out and perform all clinical protocol related tasks independently as a lead study coordinator on non-CTIMP research studies and working under supervision of more senior team members on CTIMP studies. Duties to include:
- Ensuring all site staff are trained, delegated and appropriate approvals are in place for studies.
- Patients are pre-screened, approached and recruited in a suitable way, having a detailed understanding of the informed consent process and clinical patient pathway.
- Planning of the schedule of events and study visits is taken to ensure the study is delivered safely and to protocol.
- Safely and accurately perform, record and capture administrative and clinical assessments in medical notes.
- Collect, store and transfer biological samples in accordance with study protocol, trust policies and safe shipping legal requirements.
- In an accurate and timely manner transfer source data to electronic case report forms (eCRFs) and respond to data queries.
- Monitoring of the patient within the study visit: be able to recognise and respond appropriately to deteriorating/ urgent/ emergency situations.
- Recoding and reporting of adverse events.
- Working under supervision of more senior team members, ensuring Investigation Medicinal Product procedures are performed according to staffs competency and scope of practice and to both Trust and Sponsor protocols.
- Maintaining the Investigator Site File and departmental shared drive to the highest standards.
- Maintain a suitable and in-date supply of study supplies e.g. as lab kits, needles.
- Providing Sponsors and Investigators with data and information as required and responding positively to requests.
- Coordinate and facilitate productive Sponsor, regulatory and R&D monitoring visits and responding to action items in a timely manner.
- To work according to ICH-GCP and research governance standards for clinical research studies.
- To be competent in a range of clinical skills required for research studies and be willing to undertake training for new skills.
- To be competent in a range of IT and administrative skills required for clinical research and be willing to undertake training for new skills.
- To be fully trained and competent in all aspects of study medication storage, transport and administration (within scope of practice, depending on type of professional registration): adhering to all requirements of the Clinical Trials Pharmacy Team.
- To ensure accurate and comprehensive medical and research records are maintained using appropriate documentation.
- To recognise and act on concerns raised if research deviates from the study protocol or the study design conflicts with legal or patient safety requirements.
- To identify barriers to recruitment and implement agreed action plans as required.
- To manage own caseload of non-CTIMP clinical research studies, working collaboratively with wider multidisciplinary teams.
- To be trained and delegated on all departmental research studies to provide cover for any staff absence.
- To provide thorough verbal and written handover of own workload prior to any planned leave.
- Attend meetings relevant to the clinical and research area and disseminate information to colleagues.
- To act as a knowledgeable resource in clinical practice and research, promoting an active and effective research culture.
- To ensure all departmental equipment is calibrated and maintained according to study and Trust requirements and calibration certificates are appropriate shared with Sponsors.
- To respond to patients and carers/family members in a timely, respectful and considerate manner.
- Act as advocate for patients to enable them to make informed decisions regarding study participation. There may be barriers to understanding complex clinical trials.
- Within own scope of practice and expertise, exercise professional autonomy and critical judgement when assessing patients in clinical follow up visits and when giving advice to patients on the telephone. To recognise limitations of own scope of practice and seek the support and expertise of more senior colleagues as required.
- Deliver health education within research visits and provide advice to patient, family and other members of the team.
- To liaise and communicate effectively any changes to patient care with other members of the clinical team and outside agencies as required.
- To liaise with Ward Pharmacists, Clinical Teams and Clinical Trials Pharmacy when clinical trial patients are hospitalised to ensure patient safety as prescribed drugs for hospitalisations may interact with clinical trial medication.
- Responsible for accurately entering details of patients and their treatment into clinical computer based and paper-based systems.
- Communicate with research team and/or research admin staff to ensure timely ordering of necessary stocks.
- Administration
- To work at all times in a methodical manner, with a high attention to detail.
- To manage running of own allocated clinical research studies on a day to day basis, which requires coordination with the wider team, other healthcare professionals in the multi-disciplinary team and outside agencies. To provide support and work under supervision of more senior colleagues on CTIMP studies running within the department.
- To be an expert for assigned clinical trials and to ensure the promotion and delivery of high standards of clinical care and clinical practice.
- Able to prioritize workload, delegate where appropriate and alert manager when help is required.
- Able to plan own workload in accordance with trial specific protocol and schedule of assessments.
- To promote effective working relationships between all members of staff to develop professionalism throughout the department.
- To be able to problem-solve communication barriers and act appropriately.
- Adhere to Trust policies pertaining to patient confidentiality/ GDPR /Caldicott Recommendations.
- Reimbursing patient travel expenses, providing patient refreshments and booking patient taxis.
- Education and Training
- To act in accordance with the NMC Code of Professional Conduct for Nurses, Midwives and Health Visitors and to be always accountable for own clinical practice and professional actions (Nurses only).
- To ensure continued registration with the NMC (Nurses only).
- To act in accordance with the NIHR/AHCS Standards of Proficiency for CRPs and Scope of Practice for CRPs (CRPs only)
- To be accredited or working towards accreditation on the AHCS Accredited Register for CRPs and to maintain continued registration (CRPs only)
- To participate in departmental reflection sessions between CRPs and Research Nurses as part of ongoing professional revalidation processes and to support ongoing learning and personal insight.
- To develop and maintain knowledge of cardiovascular conditions, treatments, and investigations.
- To ensure ongoing compliance with mandatory training.
- To maintain regular Good Clinical Practice training as required.
- To undertake clinical and research competencies as required.
- To undertake annual trust appraisal process to support personal and professional development.
- To support and supervise in the induction, training and ongoing development of junior staff, newly recruited staff and work experience students in the department.
- To support in the training and education of other healthcare professionals working on research studies.
- To identify and attend relevant external and local training which contributes to ongoing personal and professional development.
- To attend study training, investigator meetings and conferences as required.
- Participate significantly towards research department improvement projects, setting standards, audits and monitoring quality within the area of clinical research.
- Department Specific Requirements
- To prioritise patient safety at all times.
- To treat all research patients and their families/carers with the greatest respect and consideration, going above and beyond to ensure they have a positive experience of participating in clinical research, supporting retention in all research studies.
- To work flexibly outside of usual hours where required to meet patient, study or department needs.
- Willingness to deliver research studies in areas outside of the immediate department e.g. A&E.
- To contribute to the development of departmental policies and SOPs, adhering to these and those of the Trust at all times.
- To ensure that the Cardiac Research Department complies with ethical, regulatory, legal, Trust and R&D standards at all times.
- To attend investigator meetings, which may be international, when required.
- General
- Frequent and prolonged sitting at computer terminal.
- Travel long distances to departments and wards with which face-to-face liaison occurs (such as A&E and R &D) which are not in close proximity to the department.
Person Specification
Education/ qualifications
Essential
- 1.Undergraduate or postgraduate degree in Research or Life Sciences (for CRPs)
- 2.Current NMC registration (for Nurses)
- 3.Current GCP certificate
- 4.Evidence of continuous personal, professional, and academic development
Desirable
- oResearch specific training e.g., informed consent, lab skills, IATA
- oCurrently accredited or willing to work towards accreditation on AHCS Accredited CRP Register (for CRPs)
Knowledge and Experience
Essential
- 5.Experience working within an NHS setting
- 6.Understanding of medical terminology
- 7.Experience working as part of a multi-disciplinary team and building collaborative relationships with multiple stakeholder
- 8.Knowledge of ICH-GCP
- 9.Understanding of clinical research methodology, regulation governance and Sponsor expectations
Desirable
- oExperience in research
- oExperience working within an acute hospital setting
- oPrevious cardiology experience
Skills, Abilities and Attributes
Essential
- 10.Workload management: excellent organisational and planning skills with an ability to manage multiple tasks for multiple stakeholders at one time with excellent attention to detail
- 11.Communication: professional with patients and colleagues, with clear, confident verbal and written communication, adjusting the style and approach depending on the audience to support understanding
- 12.Source Data: excellent medical note documentation in keeping with professional, ICH-GCP and Sponsor requirements. Understanding and competency in creating, maintaining, storing and providing access to source data
- 13.Clinical: willingness to undertake training to become proficient performing clinical skills such as ECG, venepuncture, and vital signs. Willingness to learn new skills as and when required
- 14.IT skills: competent using Microsoft Office. Willingness to learn new skills and systems as required, such as clinical and sponsor systems
- 15.Flexible approach to ever changing demands of studies and caseload
- 16.Able to work autonomously, with some supervision, plan own workload and supervise junior members of the team if required
- 17.Enthusiastic and proactive approach. Ability to use own initiate and problem-solve
- 18.Flexibility to work outside regular working hours on occasions to accommodate patient and study needs
- 19.Able to carry out the duties of the post with or without adaptions
Desirable
- oGeneral cardiology knowledge
- oProcessing and shipment of lab samples.
HEART values
Essential
- 20.Demonstrate commitment to Trust HEART values - Honesty, Equality, Accountability, Respect, and Teamwork
Person Specification
Education/ qualifications
Essential
- 1.Undergraduate or postgraduate degree in Research or Life Sciences (for CRPs)
- 2.Current NMC registration (for Nurses)
- 3.Current GCP certificate
- 4.Evidence of continuous personal, professional, and academic development
Desirable
- oResearch specific training e.g., informed consent, lab skills, IATA
- oCurrently accredited or willing to work towards accreditation on AHCS Accredited CRP Register (for CRPs)
Knowledge and Experience
Essential
- 5.Experience working within an NHS setting
- 6.Understanding of medical terminology
- 7.Experience working as part of a multi-disciplinary team and building collaborative relationships with multiple stakeholder
- 8.Knowledge of ICH-GCP
- 9.Understanding of clinical research methodology, regulation governance and Sponsor expectations
Desirable
- oExperience in research
- oExperience working within an acute hospital setting
- oPrevious cardiology experience
Skills, Abilities and Attributes
Essential
- 10.Workload management: excellent organisational and planning skills with an ability to manage multiple tasks for multiple stakeholders at one time with excellent attention to detail
- 11.Communication: professional with patients and colleagues, with clear, confident verbal and written communication, adjusting the style and approach depending on the audience to support understanding
- 12.Source Data: excellent medical note documentation in keeping with professional, ICH-GCP and Sponsor requirements. Understanding and competency in creating, maintaining, storing and providing access to source data
- 13.Clinical: willingness to undertake training to become proficient performing clinical skills such as ECG, venepuncture, and vital signs. Willingness to learn new skills as and when required
- 14.IT skills: competent using Microsoft Office. Willingness to learn new skills and systems as required, such as clinical and sponsor systems
- 15.Flexible approach to ever changing demands of studies and caseload
- 16.Able to work autonomously, with some supervision, plan own workload and supervise junior members of the team if required
- 17.Enthusiastic and proactive approach. Ability to use own initiate and problem-solve
- 18.Flexibility to work outside regular working hours on occasions to accommodate patient and study needs
- 19.Able to carry out the duties of the post with or without adaptions
Desirable
- oGeneral cardiology knowledge
- oProcessing and shipment of lab samples.
HEART values
Essential
- 20.Demonstrate commitment to Trust HEART values - Honesty, Equality, Accountability, Respect, and Teamwork
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).
