Job summary
This Clinical Research Practitioner role has been created to support clinicians conducting research into Structural Heart Disease and other cardiac conditions.
The post sits within the clinical research team at the Royal Sussex County Hospital. Under supervision, the post holder will have responsibility for managing observational/non-medicinal designated research studies in the field of Structural Heart disease, including Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Mitral Valve Replacement (TMVR), Transcatheter Tricuspid Valve Replacement (TTVR), Patent Formal Ovale (PFO) and Left atrial appendage Occlusion (LAAO) procedures.
Main duties of the job
Duties include building, managing databases, data entry, supporting successful recruitment and retention of patients, strict protocol adherence, data collection, organisation of relevant tests and procedures, assisting with screening patient medical notes for eligible patients; the collection and input of data returns, patient research trial follow up activities, liaison with external trial monitors to provide timely responses to requests for information.
Work collaboratively with the other members of the research team to support the management of clinical research undertaken in the Trust, maintaining an accurate account of own designated projects status and records as required.
Work collaboratively with multi-professional groups within and outside the NHS and develop professional relationships with other relevant organisations including non-commercial bodies and pharmaceutical sponsors that promote the delivery of quality clinical research within University Hospitals Sussex.
Proactively manage change in a manner which achieves results and drives initiatives forward along a continuum of improvement in keeping with current and forthcoming organisational strategies and health trends
About us
At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Candidate Information Pack: https://www.uhsussex.nhs.uk/resources/candidate-information-pack/
Job description
Job responsibilities
Main Duties and Responsibilities
- Screen patients for suitability of entry to research studies in compliance with research protocols.
- Record patient follow-up data in source documents and study case report forms as required.
- Recognise deviations from clinical trial protocol and report to senior manager/ principal investigator/trials centre any serious adverse events or concerns regarding patient safety as defined by GCP Guidelines.
- Use own judgement to resolve day-to-day queries from trial practitioners and trial centres regarding the day-to-day activity of existing trials and the set-up of new clinical trials and procedures and organise meetings.
Planning and Organisational skills
- Organise the best use of patients and research and clinical staffs time when planning clinical trial patient care and arranging outpatient visits and follow up.
- Manage own time and workload to ensure efficient and timely data entry and study management.
- Ensure regular clinical trials reporting deadlines, etc. are maintained and data is collected and managed in a timely manner.
Patient/ Client Care
- Safeguard the wellbeing of patients by ensuring that clinical research is managed according to the UK Policy Framework for Health & Social Care and other relevant regulations such as ICH GCP.
- Ensure patient privacy and dignity is maintained when discussing or managing care of patients within clinical trials including safe handling and storage of clinical trials data or other patient identifiable documents.
- Maintain competency in required clinical skills such as venepuncture to support patient participation, support service and reduce inconvenience for patients.
- Refer patients promptly to other members of the multi-centre research team or clinical care team where appropriate.
- Request and retrieve patient medical notes as required.
Communication
- To communicate with Trust staff at a range of levels, and with a broad range of external agencies.
- To provide trial patients with required clinical trials information to support informed consent, in lay terms, and to provide them with reassurance and support.
- To communicate sensitively with patients during collection of trial follow-up data.
- To maintain good working relationships with all members of staff of the Research Department, Consultants and other clinical staff, Medical Records and Clinical Trials Co-ordinating Centres and research networks.
- To liaise with other departments e.g. pharmacy, radiology, outpatients and other hospitals to ensure protocol related investigations and assessments are conducted at specific time points to ensure continuity of care and adherence to clinical trial protocols.
Service Delivery and Improvement
Follow policies in own role and propose changes to working practices or procedures for own work area.
Assist in the production of standard operating procedures and work instructions to support the facilitation processes for research.
Appraise, interpret and apply suggestions, recommendations and directives to improve services and quality.
People Management and Development
There are no direct reports to this post.
Optional supervision of apprentices may be offered.
Learning and Development
Attend mandatory training updates as required.
Undertake training as necessary in line with the development of the post and as agreed with the line manager as part of the personal development process.
Achieve and demonstrate agreed standards of personal and professional development within agreed timescales.
Identify own learning needs and jointly plan training requirements with your line manager
Participate in the Trusts appraisal process to discuss how your role will help deliver the best possible care to our patients and help to deliver any changes in service.
Job description
Job responsibilities
Main Duties and Responsibilities
- Screen patients for suitability of entry to research studies in compliance with research protocols.
- Record patient follow-up data in source documents and study case report forms as required.
- Recognise deviations from clinical trial protocol and report to senior manager/ principal investigator/trials centre any serious adverse events or concerns regarding patient safety as defined by GCP Guidelines.
- Use own judgement to resolve day-to-day queries from trial practitioners and trial centres regarding the day-to-day activity of existing trials and the set-up of new clinical trials and procedures and organise meetings.
Planning and Organisational skills
- Organise the best use of patients and research and clinical staffs time when planning clinical trial patient care and arranging outpatient visits and follow up.
- Manage own time and workload to ensure efficient and timely data entry and study management.
- Ensure regular clinical trials reporting deadlines, etc. are maintained and data is collected and managed in a timely manner.
Patient/ Client Care
- Safeguard the wellbeing of patients by ensuring that clinical research is managed according to the UK Policy Framework for Health & Social Care and other relevant regulations such as ICH GCP.
- Ensure patient privacy and dignity is maintained when discussing or managing care of patients within clinical trials including safe handling and storage of clinical trials data or other patient identifiable documents.
- Maintain competency in required clinical skills such as venepuncture to support patient participation, support service and reduce inconvenience for patients.
- Refer patients promptly to other members of the multi-centre research team or clinical care team where appropriate.
- Request and retrieve patient medical notes as required.
Communication
- To communicate with Trust staff at a range of levels, and with a broad range of external agencies.
- To provide trial patients with required clinical trials information to support informed consent, in lay terms, and to provide them with reassurance and support.
- To communicate sensitively with patients during collection of trial follow-up data.
- To maintain good working relationships with all members of staff of the Research Department, Consultants and other clinical staff, Medical Records and Clinical Trials Co-ordinating Centres and research networks.
- To liaise with other departments e.g. pharmacy, radiology, outpatients and other hospitals to ensure protocol related investigations and assessments are conducted at specific time points to ensure continuity of care and adherence to clinical trial protocols.
Service Delivery and Improvement
Follow policies in own role and propose changes to working practices or procedures for own work area.
Assist in the production of standard operating procedures and work instructions to support the facilitation processes for research.
Appraise, interpret and apply suggestions, recommendations and directives to improve services and quality.
People Management and Development
There are no direct reports to this post.
Optional supervision of apprentices may be offered.
Learning and Development
Attend mandatory training updates as required.
Undertake training as necessary in line with the development of the post and as agreed with the line manager as part of the personal development process.
Achieve and demonstrate agreed standards of personal and professional development within agreed timescales.
Identify own learning needs and jointly plan training requirements with your line manager
Participate in the Trusts appraisal process to discuss how your role will help deliver the best possible care to our patients and help to deliver any changes in service.
Person Specification
Experience and Qualifications
Essential
- Educated to degree level or equivalent level of work experience.
- Previous clinical research experience.
- Experience of using and entering data into databases
- Previous employment within NHS/ healthcare environment
- Excellent oral and written communication skills
- Ability to communicate effectively with range of staff and patients
- Ability to work closely with clinical, academic and other staff at all levels and across the partner organisations and to develop effective working relationships.
- Ability to communicate healthcare research information in an easily understood manner
- A positive, proactive attitude
- Ability to work well as part of a team and on own initiative with minimal supervision
- A flexible and co-operative approach to team working
Desirable
- Health professional qualification
- ICH GCP training
- Experience in a research role in the NHS.
- Familiarity with medical terminology.
- Experience or an interest in working with cardiac patients
Equality, Diversity & Inclusion
Essential
- Evidence of having undertaken own development to improve understanding of equalities issues
- Evidence of having championed diversity in previous roles (as appropriate to role).
Person Specification
Experience and Qualifications
Essential
- Educated to degree level or equivalent level of work experience.
- Previous clinical research experience.
- Experience of using and entering data into databases
- Previous employment within NHS/ healthcare environment
- Excellent oral and written communication skills
- Ability to communicate effectively with range of staff and patients
- Ability to work closely with clinical, academic and other staff at all levels and across the partner organisations and to develop effective working relationships.
- Ability to communicate healthcare research information in an easily understood manner
- A positive, proactive attitude
- Ability to work well as part of a team and on own initiative with minimal supervision
- A flexible and co-operative approach to team working
Desirable
- Health professional qualification
- ICH GCP training
- Experience in a research role in the NHS.
- Familiarity with medical terminology.
- Experience or an interest in working with cardiac patients
Equality, Diversity & Inclusion
Essential
- Evidence of having undertaken own development to improve understanding of equalities issues
- Evidence of having championed diversity in previous roles (as appropriate to role).
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).
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).
