Job summary
This post will support the delivery of high-quality clinical research within the haematology research unit, covering the Lymphoid and BMT transplant studies. The post holder will be responsible for the coordination, data management, and governance of clinical trials and research studies, ensuring compliance with Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trials) Regulations, and the Research Governance Framework.
The role involves close collaboration with multidisciplinary teams, patients, and external sponsors to ensure accurate data collection, effective trial management, and adherence to all ethical and regulatory requirements.
Main duties of the job
The post holder will be responsible for data management. The post-holder will play a key role in supporting and leading on a portfolio of observational, commercial and non-commercial haematology clinical trials. Post holder will also be leading on KCH - led registry studies obtaining consent from patients as well as lead on data management on multicentre ATIMP academic studies.
Responsibilities will include completion of case report forms, day to day office management and maintenance of clinical trials documentation, processes and database.
The post holder will work closely with the trial managers, data managers, research nurses, clinical trial coordinators, clinical team and clinical trials sponsors and representatives. Assist with data monitoring ad collection from participating sites as well as management and review of standard operating procedures (SOP) to ensure compliance within the team. Attend and participate in trial meetings.
About us
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
1Data Management
Ensure accurate and timely completion of Case Report Forms (CRFs) according to trial protocol
Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
Maintain the Trial Master file (TMF) and Investigator Site File (ISF) with essential documents and version control.
Prompt query resolution
Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
Liaise with other departments and wards at the site/s, to promote a good working environment, integration of research within and open channels of communication.
Inform appropriate medical personnel and departments of portfolio of clinical trials.
Report adverse incidents and near misses via the Trusts online incident reporting form.
To contribute to the development, review and maintenance of Standard Operating Procedures (SOP).
Support internal and external monitoring and audit activities related to clinical research
Uphold the principles of Good Clinical Practice (GCP) and all relevant clinical trial regulations.
Act as a resource and support to patients and their relatives when required
Obtain Informed consent for registry studies and provide cross site cover as required.
2Governance / Quality Control
Work in accordance with all regulatory requirements including:
Local Standard Operating Procedures
Good Clinical Practice
Medicines for Human Use (Clinical Trials) Regulations
Research Governance Framework for Health and Social Care
Human Tissue Act
Administrative Responsibilities
- Provide comprehensive administrative support for research meetings, including agenda preparation, minute taking, and follow-up actions.
Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patients medical notes and trial file is transcribed accurately. To update the Trial Manager /Clinical Trials Coordinator regularly the status of such data
Assist in preparing and submitting documentation to ethics committees, regulatory authorities and R&D.
Create and maintain the file of current protocols and patient information sheets, ensuring version control. Be responsible for the maintenance of the Investigator Site Files.
Develop, update, and maintain trial-specific databases and electronic worksheets.
Formulate and maintain the databases for clinical trials.
Organise and prepare documentation for audit and monitoring visits.
Provide cover when necessary for colleagues during periods of absence.
Clinical Responsibilities
Conduct patient facing activities to include obtaining informed consent for registry studies.
Perform sample processing and shipping
Carry our basic clinical tasks such as phlebotomy and vital signs
Job description
Job responsibilities
1Data Management
Ensure accurate and timely completion of Case Report Forms (CRFs) according to trial protocol
Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
Maintain the Trial Master file (TMF) and Investigator Site File (ISF) with essential documents and version control.
Prompt query resolution
Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
Liaise with other departments and wards at the site/s, to promote a good working environment, integration of research within and open channels of communication.
Inform appropriate medical personnel and departments of portfolio of clinical trials.
Report adverse incidents and near misses via the Trusts online incident reporting form.
To contribute to the development, review and maintenance of Standard Operating Procedures (SOP).
Support internal and external monitoring and audit activities related to clinical research
Uphold the principles of Good Clinical Practice (GCP) and all relevant clinical trial regulations.
Act as a resource and support to patients and their relatives when required
Obtain Informed consent for registry studies and provide cross site cover as required.
2Governance / Quality Control
Work in accordance with all regulatory requirements including:
Local Standard Operating Procedures
Good Clinical Practice
Medicines for Human Use (Clinical Trials) Regulations
Research Governance Framework for Health and Social Care
Human Tissue Act
Administrative Responsibilities
- Provide comprehensive administrative support for research meetings, including agenda preparation, minute taking, and follow-up actions.
Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patients medical notes and trial file is transcribed accurately. To update the Trial Manager /Clinical Trials Coordinator regularly the status of such data
Assist in preparing and submitting documentation to ethics committees, regulatory authorities and R&D.
Create and maintain the file of current protocols and patient information sheets, ensuring version control. Be responsible for the maintenance of the Investigator Site Files.
Develop, update, and maintain trial-specific databases and electronic worksheets.
Formulate and maintain the databases for clinical trials.
Organise and prepare documentation for audit and monitoring visits.
Provide cover when necessary for colleagues during periods of absence.
Clinical Responsibilities
Conduct patient facing activities to include obtaining informed consent for registry studies.
Perform sample processing and shipping
Carry our basic clinical tasks such as phlebotomy and vital signs
Person Specification
Essential/Desirable
Essential
- BSc or Life Science degree
- Evidence of continuous personal, professional, and academic development
- GCP qualification
- Knowledge and experience with Multidisciplinary team and internal & external stakeholders
- Excellent attention to detail and data accuracy
- Previous experience within haematology oncology; or research
- Understanding of Research Governance and Ethics procedures
- Knowledge of clinical trial activity & ability to relay information to other professionals involved in patient care
- Proficient in database management and Microsoft Office applications.
- Analytical Skills
- Data Collection, entry & filing evidence
- Ability to work in a team and flexibility to travel cross site
- Planning & organisational Skills
Desirable
- Advanced IT skills (ECDL) or equivalent
- Previous experience within haematology oncology; or research
- Basic clinical Skills; phlebotomy, Vital signs
Person Specification
Essential/Desirable
Essential
- BSc or Life Science degree
- Evidence of continuous personal, professional, and academic development
- GCP qualification
- Knowledge and experience with Multidisciplinary team and internal & external stakeholders
- Excellent attention to detail and data accuracy
- Previous experience within haematology oncology; or research
- Understanding of Research Governance and Ethics procedures
- Knowledge of clinical trial activity & ability to relay information to other professionals involved in patient care
- Proficient in database management and Microsoft Office applications.
- Analytical Skills
- Data Collection, entry & filing evidence
- Ability to work in a team and flexibility to travel cross site
- Planning & organisational Skills
Desirable
- Advanced IT skills (ECDL) or equivalent
- Previous experience within haematology oncology; or research
- Basic clinical Skills; phlebotomy, Vital signs
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).
