Job summary
The post-holder will work as part of the RDU 1 Research Delivery team for Stroke Research Team. The post holder will cover the workload and responsibilities of his/her colleagues during their absence. The post-holder will report to the Research Manager who will be responsible for managing the requirements and demands for research delivery support across the research programmes and themes.
The post-holder will be based at the Stroke Research Office at King's College Hospital and work in close liaison with the principal investigators at King's College Hospital NHS Foundation Trust and at the Princess Royal University Hospital (PRUH ) site in Orpington. The post-holder will be required, on occasions, to see study patients and to recruit new patients into studies, at the PRUH.
The post is fixed-term for 12 months.
Note: due to high demand for the post, this application will close earlier than the proposed closing date
Main duties of the job
The post-holder will be involved in ensuring that any research undertaken at this recruiting site safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. The post holder will undertake all relevant responsibilities as study coordinator and will ensure high quality of the research by maintaining high standards throughout the study as well as good data integrity. This includes commercial and non-commercial NIHR portfolio studies as well as investigator-led studies. As study coordinator, the post holder will be expected to report serious adverse events in a timely mannerThe post-holder will be responsible for recruiting to target, carrying out routine research study procedures, keeping accurate administrative records, and managing data entries and data queries in a timely manner.
The post-holder will also be responsible for ensuring data integrity by carrying out regular quality assurance checks. Other aspects of the role will include clinical tasks such as phlebotomy, cannulation, processing of blood and urine specimens, drug administration and clinical observations.
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
Work autonomously to manage and coordinate own study portfolio within the designated areas of responsibility, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery.
Be responsible for the whole patient recruitment process from selection to screening and from randomisation to the scheduling of study visits. Evaluate patient eligibility for the trial, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the research protocol.
Ensure patients are fully informed prior to entry into the clinical research programme and play a key role in eliciting informed consent to participate. To provide ongoing advice and information to patients with regards to their participation in clinical research in order to facilitate effective informed consent.
Act as a resource and support to patients and their relatives, explaining practical aspects of the trial, assisting and supporting local nursing teams when necessary.
Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that the trial is conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.
Coordinate the collection of any biological samples required as part of the clinical trial and ensure safe and appropriate storage of specimens. Monitoring and recording daily freezer and fridge temperatures and reporting any temperature excursions to the Clinical Research Nurse/Manager.
Ensure the safe administration of the investigational medicinal product (IMP), have in-depth knowledge of the legal requirements of the individual Trusts clinical trial pharmacovigilance and pharmacovigilance policies. Report any adverse events and reactions in accordance with this policy and the trial protocol. Report any serious adverse events within 24 hours of knowledge of the event, to the sponsors. (For non-commercial studies please use the appropriate SAE forms supplied by the host sites. For KCH & GSTT-sponsored non-commercial studies, please use KHPCTO forms).
Maintain clear and accurate source data and other records; ensure a high level of accuracy when transcribing data onto electronic or paper case report forms; create and design database as required for patient and staff records.
Assist the PIs in liaising with the KHPCTO and R&I Office relating to submission of the study for regulatory approval and Trust Management approval. Assist in completing submissions to the Research Health Authority (RHA) as required.
Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation and keep up to date with current practices for cannulation, phlebotomy, etc.
To oversee the routine maintenance and servicing of research equipment. To ensure that all research equipment is calibrated annually and that the calibration certificates are filed in the Equipment File. Ensure that the freezers are maintained in good conditions. Perform essential tasks to prevent build-up of ice around the frame of the freezer doors.
Liaise with the Research Nurses regarding administration of trial drugs to your study patients.
Be responsible for the accountability of the oral medication used by your study patients.
Job description
Job responsibilities
Work autonomously to manage and coordinate own study portfolio within the designated areas of responsibility, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery.
Be responsible for the whole patient recruitment process from selection to screening and from randomisation to the scheduling of study visits. Evaluate patient eligibility for the trial, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the research protocol.
Ensure patients are fully informed prior to entry into the clinical research programme and play a key role in eliciting informed consent to participate. To provide ongoing advice and information to patients with regards to their participation in clinical research in order to facilitate effective informed consent.
Act as a resource and support to patients and their relatives, explaining practical aspects of the trial, assisting and supporting local nursing teams when necessary.
Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that the trial is conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.
Coordinate the collection of any biological samples required as part of the clinical trial and ensure safe and appropriate storage of specimens. Monitoring and recording daily freezer and fridge temperatures and reporting any temperature excursions to the Clinical Research Nurse/Manager.
Ensure the safe administration of the investigational medicinal product (IMP), have in-depth knowledge of the legal requirements of the individual Trusts clinical trial pharmacovigilance and pharmacovigilance policies. Report any adverse events and reactions in accordance with this policy and the trial protocol. Report any serious adverse events within 24 hours of knowledge of the event, to the sponsors. (For non-commercial studies please use the appropriate SAE forms supplied by the host sites. For KCH & GSTT-sponsored non-commercial studies, please use KHPCTO forms).
Maintain clear and accurate source data and other records; ensure a high level of accuracy when transcribing data onto electronic or paper case report forms; create and design database as required for patient and staff records.
Assist the PIs in liaising with the KHPCTO and R&I Office relating to submission of the study for regulatory approval and Trust Management approval. Assist in completing submissions to the Research Health Authority (RHA) as required.
Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation and keep up to date with current practices for cannulation, phlebotomy, etc.
To oversee the routine maintenance and servicing of research equipment. To ensure that all research equipment is calibrated annually and that the calibration certificates are filed in the Equipment File. Ensure that the freezers are maintained in good conditions. Perform essential tasks to prevent build-up of ice around the frame of the freezer doors.
Liaise with the Research Nurses regarding administration of trial drugs to your study patients.
Be responsible for the accountability of the oral medication used by your study patients.
Person Specification
Qualifications
Essential
Desirable
- Degree level of Equivalent
Skills
Essential
- Good communication and interpersonal skills
- Computer literacy & competence in standard pc packages
Desirable
- Venepuncture & cannulation
Knowledge and experience
Essential
- A good understanding of research governance and ethics
- Knowledge of NHS/clinical setting
- Awareness of the need for discretion and confidentiality
Desirable
- Experience in the research setting as a Band 3
- Some experience of working with Stroke patients
- Experience in liaising with study monitors and sponsors
Abilities
Essential
- Ability to work under pressure
- Ability to work independently and as part of a team
- Ability to impart study information to patients, relatives and carers, with different levels of understanding
- Ability to enter data onto sponsors' EDC systems accurately and in a timely manner
- Ability to interact sensitively and professionally with clinical staff and patients
Person Specification
Qualifications
Essential
Desirable
- Degree level of Equivalent
Skills
Essential
- Good communication and interpersonal skills
- Computer literacy & competence in standard pc packages
Desirable
- Venepuncture & cannulation
Knowledge and experience
Essential
- A good understanding of research governance and ethics
- Knowledge of NHS/clinical setting
- Awareness of the need for discretion and confidentiality
Desirable
- Experience in the research setting as a Band 3
- Some experience of working with Stroke patients
- Experience in liaising with study monitors and sponsors
Abilities
Essential
- Ability to work under pressure
- Ability to work independently and as part of a team
- Ability to impart study information to patients, relatives and carers, with different levels of understanding
- Ability to enter data onto sponsors' EDC systems accurately and in a timely manner
- Ability to interact sensitively and professionally with clinical staff and patients
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).
