Job summary
This post will be based at the Denmark Hill site within the remit of the NIHR Clinical Research Facility. We cater for all investigators of Kings Health Partners (KHP) and beyond and have responsibility for new and existing clinical trials and clinical research projects on the King's CRF portfolio, including Clinical Trials of Investigational Medicinal Products under the EU Directive (CTIMPs).
The key job functions of the Clinical Trials Coordinator are:
To co-ordinate the set-up and conduct of clinical trials and/or clinical studies working closely with the chief investigators and their teams.
Set-up participating sites in multi-centre trials and ensuring that all data and samples are collected following the protocol.
Please note that this advert may close early if a sufficient number of applications is received. We strongly encourage interested candidates to apply as soon as possible.
Main duties of the job
The postholder will play a key role in coordinating the start-up and delivery of clinical trials within the Clinical Research Facility (CRF), ensuring compliance with ICH GCP, UK regulations, and sponsor requirements. Responsibilities include managing essential study documentation, supporting regulatory submissions, and liaising with sponsors, investigators, and research teams to achieve timely site activation and smooth study conduct from set-up through to close-out. The role will involve maintaining accurate records across national and local systems, supporting the management of investigational products and biosamples, and providing advice and guidance to research teams and patients. The postholder will act as the main point of contact for start-up activities, represent the CRF at internal and external meetings, and contribute to performance monitoring, reporting, and continuous improvement initiatives. They will also support training and development of colleagues and investigators to ensure consistent, high-quality research delivery.
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
Operational Performance
Initiate and coordinate all activities and essential document management during start-up, aiming for a high-quality Investigator Site File (ISF) to support regulatory greenlight and timely site initiation, across both commercial and non-commercial studies.
- Coordinate, balance, and facilitate activities related to the completion of the Critical Document Package and the Investigational Product (IP) Release Checklist in accordance with ICH GCP, UK regulations, sponsor requirements, and ethical standards.
- Liaise with sponsors to confirm site readiness by completing and reviewing study-specific Critical Information Sheets, including local and investigator initiation package documents, IRB submission status, payment details, and clinical supply logistics.
- Coordinate all required document translations during study start-up, ensuring accuracy and timely delivery to maintain progress against the 150-day metric.
- Work with internal and external stakeholders to ensure rapid, compliant, and high-quality site activation processes, identifying and resolving any obstacles to study initiation.
- Attend study team meetings and site start-up calls as required to represent the CRF and maintain oversight of study timelines and expectations.
- Ensure that the entire start-up process remains focused on quality, efficiency, and cost-effectiveness, contributing to improved site delivery performance and King's CRF reputation.
- Coordinate all aspects of the day to day conduct of clinical trials/studies from set-up to close down in accordance with ICH GCP, NHS Research Governance and, for Clinical Trials of Investigational Medicinal Products (CTIMPs), the EU Directive on clinical trials
Administrative Responsibilities
- Manage the compilation, version control, and filing of essential documents within both electronic and physical Investigator Site Files (ISFs) during the start-up phase.
- Maintain up-to-date records in internal and national systems (e.g., EDGE, CPMS), ensuring accurate reflection of progress in relation to study approvals, greenlight status, and start-up timelines.
- Perform timely and accurate data entry of all relevant study start-up activities into tracking systems to ensure performance monitoring and reporting compliance.
- Liaise with members of research teams and provide on-going advice and support to ensure the smooth conduct of clinical research ensuring compliance with study protocol, and all relevant guidelines, regulations and legislation.
- Coordinate the receipt, transfer and storage of any clinical materials or biosamples collected during the study in accordance with GCP guidelines.
- Answer e-mails and/or telephone calls from members of the public/carers/patients regarding research related queries i.e. in regards to a specific illness, how to participate in clinical trials etc.
- Prepare, submit and manage amendments to essential clinical research documentation.
- Ensure close-out procedures at sites are performed as required and are archived.
- Undertake any other duties that may be required from time to time, as are consistent with the responsibilities of the grade and needs of the service.
Ability to familiarise with the facilities standard operating procedures (SOPs), including keeping personal training records up to date.
Recording patient information on the electronic patient record system (EPIC), including data management and requests.
Communication and Representation
- Act as the primary point of contact for all start-up related queries from internal and external stakeholders.
- Represent the CRF at internal and external meetings related to study set-up and performance.
- Provide guidance to investigators and research teams on start-up requirements.
- Establish and maintain good working relationships with various professionals including members of King's CRF, Trust R&D, investigators and their teams as well as external stakeholders (e.g. REC, MHRA, CLRN, other R&D departments, universities and research teams) and provide them with timely information when required.
Job description
Job responsibilities
Operational Performance
Initiate and coordinate all activities and essential document management during start-up, aiming for a high-quality Investigator Site File (ISF) to support regulatory greenlight and timely site initiation, across both commercial and non-commercial studies.
- Coordinate, balance, and facilitate activities related to the completion of the Critical Document Package and the Investigational Product (IP) Release Checklist in accordance with ICH GCP, UK regulations, sponsor requirements, and ethical standards.
- Liaise with sponsors to confirm site readiness by completing and reviewing study-specific Critical Information Sheets, including local and investigator initiation package documents, IRB submission status, payment details, and clinical supply logistics.
- Coordinate all required document translations during study start-up, ensuring accuracy and timely delivery to maintain progress against the 150-day metric.
- Work with internal and external stakeholders to ensure rapid, compliant, and high-quality site activation processes, identifying and resolving any obstacles to study initiation.
- Attend study team meetings and site start-up calls as required to represent the CRF and maintain oversight of study timelines and expectations.
- Ensure that the entire start-up process remains focused on quality, efficiency, and cost-effectiveness, contributing to improved site delivery performance and King's CRF reputation.
- Coordinate all aspects of the day to day conduct of clinical trials/studies from set-up to close down in accordance with ICH GCP, NHS Research Governance and, for Clinical Trials of Investigational Medicinal Products (CTIMPs), the EU Directive on clinical trials
Administrative Responsibilities
- Manage the compilation, version control, and filing of essential documents within both electronic and physical Investigator Site Files (ISFs) during the start-up phase.
- Maintain up-to-date records in internal and national systems (e.g., EDGE, CPMS), ensuring accurate reflection of progress in relation to study approvals, greenlight status, and start-up timelines.
- Perform timely and accurate data entry of all relevant study start-up activities into tracking systems to ensure performance monitoring and reporting compliance.
- Liaise with members of research teams and provide on-going advice and support to ensure the smooth conduct of clinical research ensuring compliance with study protocol, and all relevant guidelines, regulations and legislation.
- Coordinate the receipt, transfer and storage of any clinical materials or biosamples collected during the study in accordance with GCP guidelines.
- Answer e-mails and/or telephone calls from members of the public/carers/patients regarding research related queries i.e. in regards to a specific illness, how to participate in clinical trials etc.
- Prepare, submit and manage amendments to essential clinical research documentation.
- Ensure close-out procedures at sites are performed as required and are archived.
- Undertake any other duties that may be required from time to time, as are consistent with the responsibilities of the grade and needs of the service.
Ability to familiarise with the facilities standard operating procedures (SOPs), including keeping personal training records up to date.
Recording patient information on the electronic patient record system (EPIC), including data management and requests.
Communication and Representation
- Act as the primary point of contact for all start-up related queries from internal and external stakeholders.
- Represent the CRF at internal and external meetings related to study set-up and performance.
- Provide guidance to investigators and research teams on start-up requirements.
- Establish and maintain good working relationships with various professionals including members of King's CRF, Trust R&D, investigators and their teams as well as external stakeholders (e.g. REC, MHRA, CLRN, other R&D departments, universities and research teams) and provide them with timely information when required.
Person Specification
Education and Qualification
Essential
- Life Sciences or health-related degree (or equivalent experience)
- Good Clinical Practice (GCP) certification
Knowledge and Experience
Essential
- Demonstrated experience in clinical research, ideally in study start-up
- Experience working with research tracking systems (e.g., EDGE, CPMS, IRAS)
Desirable
- Experience with research electronic case report database (e.g. RAVE medidata, RedCAP, Capture etc
- Previous direct clinical trials and/or project management experience
Skills and Competencies
Essential
- Strong project coordination and organisational skills
- Excellent written and verbal communication
- Ability to use Microsoft Office to an advanced level
Person Specification
Education and Qualification
Essential
- Life Sciences or health-related degree (or equivalent experience)
- Good Clinical Practice (GCP) certification
Knowledge and Experience
Essential
- Demonstrated experience in clinical research, ideally in study start-up
- Experience working with research tracking systems (e.g., EDGE, CPMS, IRAS)
Desirable
- Experience with research electronic case report database (e.g. RAVE medidata, RedCAP, Capture etc
- Previous direct clinical trials and/or project management experience
Skills and Competencies
Essential
- Strong project coordination and organisational skills
- Excellent written and verbal communication
- Ability to use Microsoft Office to an advanced level
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).
