Overview
This post will be based at the Denmark Hill site within the remit of the NIHR Clinical Research Facility (CRF). The CRF caters for all investigators of Kings Health Partners (KHP) and beyond and has 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, and set-up participating sites in multi-centre trials with data and sample collection following the protocol.
Responsibilities
* Operational Performance
o Initiate and coordinate all activities and essential document management during start-up to support regulatory greenlight and timely site initiation, across both commercial and non-commercial studies.
o Coordinate the Critical Document Package and Investigational Product (IP) Release Checklist in line with ICH GCP, UK regulations, sponsor requirements and ethical standards.
o liaise with sponsors to confirm site readiness by completing and reviewing study-specific documents (Critical Information Sheets, local and investigator initiation package documents, IRB submission status, payment details, clinical supply logistics).
o Coordinate translation of required documents during start-up to maintain progress against the 150-day metric.
o Work with internal and external stakeholders to enable rapid, compliant site activation and resolve obstacles to study initiation.
o Attend study team meetings and site start-up calls to represent the CRF and monitor timelines and expectations.
o Ensure the start-up process focuses on quality, efficiency, and cost-effectiveness to improve site delivery and the CRF reputation.
o Coordinate day-to-day conduct of trials from set-up to close-down in accordance with ICH GCP, NHS Research Governance, and CTIMPs/EU Directive requirements.
* Administrative Responsibilities
o Compile, version control, and file essential documents in electronic and physical ISFs during start-up.
o Maintain records in internal and national systems (e.g., EDGE, CPMS) reflecting progress, approvals, greenlight status, and start-up timelines.
o Enter start-up activities into tracking systems for performance monitoring and reporting compliance.
o Provide ongoing guidance to research teams to ensure the smooth conduct of clinical research in line with study protocol and regulations.
o Coordinate receipt, transfer, and storage of clinical materials or biosamples per GCP guidelines.
o Respond to public/patient inquiries regarding participation in clinical trials.
o Prepare, submit, and manage amendments to essential clinical research documentation.
o Ensure close-out procedures at sites are performed and archived.
o Undertake other duties as required by the grade and service needs.
Ability to familiarise with the facilities’ standard operating procedures (SOPs), keep training records up to date, and record 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 relationships with King’s CRF, Trust R&D, investigators and external stakeholders (e.g., REC, MHRA, CLRN, universities) and provide timely information as 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 with research tracking systems (e.g., EDGE, CPMS, IRAS)
Desirable
* Experience with research electronic data capture databases (e.g., Medidata RAVE, REDCap, Capture)
* Previous direct clinical trials and/or project management experience
Skills and Competencies
Essential
* Strong project coordination and organisational skills
* Excellent written and verbal communication
* Advanced Microsoft Office skills
Other Information
This post is subject to the Rehabilitation of Offenders Act 1975; a Disclosure to the Disclosure and Barring Service (formerly CRB) is required. Applications from job seekers who require Skilled Worker sponsorship to work in the UK will be considered. See UK Visas and Immigration guidance for details. See also information on criminal records checks for overseas applicants.
Employer: King’s College Hospital NHS Foundation Trust, Denmark Hill, London, SE5 9RS. Website: https://www.kch.nhs.uk/
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