Job summary
The post holder will assist in the provision of a clinical research service for a portfolio of national and local, including RDN-adopted, clinical trials undertaken at King's College Hospital NHS Foundation Trust within the Neurosciences department. The focus of the work will be on portfolio adopted studies, non-commercial and commercial. This will be decided after liaison with Neurosciences R&D lead and Neurosciences Research Governance and Feasibility (RGF).
The post holder will also be involved in follow-up and completion of relevant trial specific paperwork. Responsibilities will include co-ordinating patient activity and overseeing patient care at all stages of the research pathway; data management (collecting data, entering data and resolving discrepancies) and working with clinical research organisations and sponsors to satisfy audit and monitoring requirements. With respect to multi-centre trials sponsored by KCH, the post holder will be expected to support investigators and their teams at recruiting sites.
The post holder will work closely with the multidisciplinary team, including but not restricted to the Investigators, Research Manager, clinicians, Research Governance and pharmacy. The post holder will be involved in the running of in-house, national and international Neurosciences trials.
Main duties of the job
Ensure all relevant documents and approvals are in place at each site prior to subject recruitment.
Identify patients suitable for entry into clinical trials by attending clinics, Multidisciplinary Team (MDT) meetings, and screening electronic and paper patient notes,.
Ensure patients are fully informed prior to entry in any clinical trial programme.
Assist in consenting, randomising, allocating of treatment of patients.
Evaluate patient eligibility for clinical trials entry by co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
Coordinate all ongoing study visits and investigations as per the protocol.
Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials.
Coordinate the collection of any biological samples required as part of the clinical trials and ensure safe and appropriate storage of specimens.
Maintain adequate and accurate patient records and ensure all relevant information is documented in the patient's medical notes.
Ensure accurate and timely completion of Case Report Forms (CRFs).
Manage the co-ordination and computerisation of data generated from clinical trials.
Provide specific advice and signposting to support as appropriate.
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£1.8 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
Assist in the review of trial protocols and identify resource implications for the site.
Liaise with and assist the medical team/sponsor organisation with on-study treatment and follow up of patients
Assist with the recording and reporting of SAEs and other incidents in accordance with the protocol and/or sponsors SOP.
Ensure that all accrual data is uploaded onto the EDGE database (the Trusts clinical trial management system).
Supervise and support the Collecting and provision of information to allow for invoices to be raised for payments where appropriate
Liaise with other departments and raise awareness of the portfolio of current clinical trials within the organisation.
Participate in the presentation of research findings within the Clinical Research Network and outside agencies as appropriate.
Report adverse incidents and near misses via the Trusts online incident reporting system.
Any other duties of a similar nature as requested by the RDU Managers and supervisors
At all times adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
Keep up to date with current practices for cannulation, phlebotomy and care of patients with Central Venous Access lines.
Provide line management to the RDU Administration Support Officer
Job description
Job responsibilities
Assist in the review of trial protocols and identify resource implications for the site.
Liaise with and assist the medical team/sponsor organisation with on-study treatment and follow up of patients
Assist with the recording and reporting of SAEs and other incidents in accordance with the protocol and/or sponsors SOP.
Ensure that all accrual data is uploaded onto the EDGE database (the Trusts clinical trial management system).
Supervise and support the Collecting and provision of information to allow for invoices to be raised for payments where appropriate
Liaise with other departments and raise awareness of the portfolio of current clinical trials within the organisation.
Participate in the presentation of research findings within the Clinical Research Network and outside agencies as appropriate.
Report adverse incidents and near misses via the Trusts online incident reporting system.
Any other duties of a similar nature as requested by the RDU Managers and supervisors
At all times adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
Keep up to date with current practices for cannulation, phlebotomy and care of patients with Central Venous Access lines.
Provide line management to the RDU Administration Support Officer
Person Specification
Education and Qualifications
Essential
- Life Sciences (or equivalent) degree or relevant experience
- Evidence of continuous personal, professional and academic development
Desirable
Knowledge and Experience
Essential
- Experience of working in a research delivery role
- Understanding of Regulatory requirements pertaining to clinical trials
- Previous experience in the NHS or in a Higher Education setting
Desirable
- Ability to handle complex relationships
Skills and Competencies
Essential
- Excellent communication and interpersonal skills
- Excellent IT skills in the following areas: ?Word processing ?Communication software - all functions of MS Outlook ?Internet searching Spreadsheets - producing multi-sheet tables, graphs, sorting and filtering
- Excellent attention to detail and accuracy in data collection
- Ability to work under pressure and exercise judgement when dealing with inquiries
- Excellent problem solving skills
- Ability to work without supervision and use own initiative
- Ability to prioritise; to be organised and flexible. Able to effectively accommodate ad hoc demands to existing workload
Desirable
- Able to demonstrate tact and diplomacy
- Report writing and presentational skills
- Experience of Data Input
Person Specification
Education and Qualifications
Essential
- Life Sciences (or equivalent) degree or relevant experience
- Evidence of continuous personal, professional and academic development
Desirable
Knowledge and Experience
Essential
- Experience of working in a research delivery role
- Understanding of Regulatory requirements pertaining to clinical trials
- Previous experience in the NHS or in a Higher Education setting
Desirable
- Ability to handle complex relationships
Skills and Competencies
Essential
- Excellent communication and interpersonal skills
- Excellent IT skills in the following areas: ?Word processing ?Communication software - all functions of MS Outlook ?Internet searching Spreadsheets - producing multi-sheet tables, graphs, sorting and filtering
- Excellent attention to detail and accuracy in data collection
- Ability to work under pressure and exercise judgement when dealing with inquiries
- Excellent problem solving skills
- Ability to work without supervision and use own initiative
- Ability to prioritise; to be organised and flexible. Able to effectively accommodate ad hoc demands to existing workload
Desirable
- Able to demonstrate tact and diplomacy
- Report writing and presentational skills
- Experience of Data Input
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).
