Job summary
The post holder will be responsible for coordinating the IMPACT clinical trials and providing support to other trials within the Haematology Research Unit as needed.
The post holder will work as part of a team and independently, assisting the senior trial lead and guiding junior staff when necessary. The main tasks include overseeing the trial protocol, prioritizing trial governance and patient safety, and attending clinical settings to coordinate the trial and identify suitable patients.
The post holder will collaborate with qualified staff, ensuring drug administration and clinical nursing tasks align with the trial protocol and guidelines. If qualified, they may administer trial drugs and report any side effects in accordance with the protocol and good clinical practice.
Main duties of the job
The post holder will support the development and implementation of strategies to maintain and increase the level of patient recruitment into haematology clinical trials within KCH.
You will work in support with the Senior Trials Coordinator/ Research Nurse to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) and ensuring a duty of care to the patient and their families.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
Job description
Job responsibilities
KEY AREAS OF RESPONSIBILITY
Clinical Responsibilities
Work in support / conjunction with the Senior Clinical Trials Coordinator/Clinical Trials Practitioner to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) and ensuring a duty of care to the patient and their families. Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings. Be aware of and on occasion (and if trained and on the approval log) participate in the informed consent process Support and help coordinate the research patient pathway from screening through to trial closure Ensure that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products. Be aware of and report any side effects as outlined in the protocol, in association with local nursing teams. Maintain adequate patients records and ensure all relevant information is documented in the patients medical and nursing notes. Be responsible for accurate completion of Case Report Forms (CRFs) delegated to them. Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. If appropriately trained, undertake agreed procedures, in line with trial and Trust procedures, to include: venepuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 sats and respiratory rate. If not appropriately training, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures. Act as a role model for excellence in haematology based research.
Portfolio Management and Development
Review trial protocols and support the Clinical Trial Lead to identify resource implications for the site. Liaise with the clinical trial lead, medical team/sponsor organisation to co-ordinate the on-study treatment and patient follow up. Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials on site. Assist in completing submissions to Research & Development departments of relevant sites. Process amendments and disseminate information to relevant departments Ensure that accrual data is reported to the Sponsors as required. To be able to provide information to allow for invoice to be raised for payments where appropriate Build strong professional relationships with other departments in order to promote a good working environment. Participate in the presentation of research findings within the Trust. To report adverse incidents and near misses in line with Trust policy. Support the Clinical Trial lead to maintain a dialogue of progress with the Clinical Trials Manager, lead trial consultant and lead investigator. Attend monthly portfolio performance review meetings: identify and act on issues. Provide cover when necessary for annual leave, study leave, sick leave.
Professional Development and Leadership
The post holder will support the development and implementation of strategies to maintain and increase the level of patient recruitment into haematology clinical trials within KCH and wherever possible help to maintain the high profile of KCH in line with the Haematology strategy To innovate and contribute to the development of Network wide clinical and research policies and procedures. To support the senior clinical trials coordinator and clinical trials manager in ensuring that the Trust is meeting the accrual targets for both CLRN and commercial trials and to take action to address any shortfalls. To implement strategies and systems for quality assurance Attend the training programmes and other relevant education and training days as agreed in your development plan. Attend investigator meetings and conferences when required Takes personal responsibility for own professional growth, keep up to date with professional development and research and to undertake an annual appraisal (internal performance review) to identify personal objectives and development needs Prepare posters/research papers for meetings, conferences and publications. Represent the research team at local and national forums Participate in service development. Support other members of the team Manage and ensure adherence to trust policies throughout the team.
GENERAL
The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations. To observe and maintain strict confidentiality of personal information relating to patients and staff. To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues. This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder. The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene requirements of this role. These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all times.
This job description does not contain an exhaustive list of duties and you may be required to undertake additional responsibilities. Periodic review will occur in order to adapt and develop the role according to the service needs and hospital policies.
Job description
Job responsibilities
KEY AREAS OF RESPONSIBILITY
Clinical Responsibilities
Work in support / conjunction with the Senior Clinical Trials Coordinator/Clinical Trials Practitioner to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) and ensuring a duty of care to the patient and their families. Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings. Be aware of and on occasion (and if trained and on the approval log) participate in the informed consent process Support and help coordinate the research patient pathway from screening through to trial closure Ensure that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products. Be aware of and report any side effects as outlined in the protocol, in association with local nursing teams. Maintain adequate patients records and ensure all relevant information is documented in the patients medical and nursing notes. Be responsible for accurate completion of Case Report Forms (CRFs) delegated to them. Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. If appropriately trained, undertake agreed procedures, in line with trial and Trust procedures, to include: venepuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 sats and respiratory rate. If not appropriately training, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures. Act as a role model for excellence in haematology based research.
Portfolio Management and Development
Review trial protocols and support the Clinical Trial Lead to identify resource implications for the site. Liaise with the clinical trial lead, medical team/sponsor organisation to co-ordinate the on-study treatment and patient follow up. Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials on site. Assist in completing submissions to Research & Development departments of relevant sites. Process amendments and disseminate information to relevant departments Ensure that accrual data is reported to the Sponsors as required. To be able to provide information to allow for invoice to be raised for payments where appropriate Build strong professional relationships with other departments in order to promote a good working environment. Participate in the presentation of research findings within the Trust. To report adverse incidents and near misses in line with Trust policy. Support the Clinical Trial lead to maintain a dialogue of progress with the Clinical Trials Manager, lead trial consultant and lead investigator. Attend monthly portfolio performance review meetings: identify and act on issues. Provide cover when necessary for annual leave, study leave, sick leave.
Professional Development and Leadership
The post holder will support the development and implementation of strategies to maintain and increase the level of patient recruitment into haematology clinical trials within KCH and wherever possible help to maintain the high profile of KCH in line with the Haematology strategy To innovate and contribute to the development of Network wide clinical and research policies and procedures. To support the senior clinical trials coordinator and clinical trials manager in ensuring that the Trust is meeting the accrual targets for both CLRN and commercial trials and to take action to address any shortfalls. To implement strategies and systems for quality assurance Attend the training programmes and other relevant education and training days as agreed in your development plan. Attend investigator meetings and conferences when required Takes personal responsibility for own professional growth, keep up to date with professional development and research and to undertake an annual appraisal (internal performance review) to identify personal objectives and development needs Prepare posters/research papers for meetings, conferences and publications. Represent the research team at local and national forums Participate in service development. Support other members of the team Manage and ensure adherence to trust policies throughout the team.
GENERAL
The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations. To observe and maintain strict confidentiality of personal information relating to patients and staff. To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues. This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder. The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene requirements of this role. These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all times.
This job description does not contain an exhaustive list of duties and you may be required to undertake additional responsibilities. Periodic review will occur in order to adapt and develop the role according to the service needs and hospital policies.
Person Specification
Qualifications
Essential
- Education - NMC Registration
- Research Experience including research governance awareness
- Communication
- IT - Knowledge/ Skill/ Ability
Desirable
- GCP qualification
- Experience in leading on studies
- Phlebotomy Experience
Previous experience
Essential
- Knowledge and experience of working with different profession groups and handling relationships
- Previous research or clinical trial experience
Desirable
- Previous post-registration experience within the oncology/research/haematology setting
- Experience of collaborating with other agencies
Skills/Knowledge/Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Evidence of accuracy to detail in data collection
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Report writing and presentational skills
Person Specification
Qualifications
Essential
- Education - NMC Registration
- Research Experience including research governance awareness
- Communication
- IT - Knowledge/ Skill/ Ability
Desirable
- GCP qualification
- Experience in leading on studies
- Phlebotomy Experience
Previous experience
Essential
- Knowledge and experience of working with different profession groups and handling relationships
- Previous research or clinical trial experience
Desirable
- Previous post-registration experience within the oncology/research/haematology setting
- Experience of collaborating with other agencies
Skills/Knowledge/Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Evidence of accuracy to detail in data collection
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Report writing and presentational skills
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).
