Job id: 089705. Salary: £37,332 – £42,099 per annum, including London Weighting Allowance.
Posted: 16 May 2024. Closing date: 09 June 2024.
Business unit: Research Management & Innovation. Department: KHP Clinical Trials Office.
Contact details:Emma Gray. [email protected]
Location: Guy's Campus. Category: Research.
Job description
This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations; therefore, the university will not be able to offer sponsorship for this role.
The KHP-CTO Quality Team was established in 2008 to manage the sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. The team assists Chief Investigators with the set-up, initiation, maintenance and closure of their trials and ensures that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations.
The Post holder will;
- co-monitor and monitor CTIMP trials on behalf of the sponsor to ensure regulatory GCP compliance.
- To provide support to investigators conducting trials to ensure they are working to the highest quality standards and to monitor and report on the progress of trial sites across UK and some EU countries.
- To assist the Senior CRAs to ensure that investigators and their teams run the trial according to sponsor’s SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out monitoring functions as appropriate.
This post will be offered on an indefinite contract
This is a full-time post - 100% full time equivalent
Key responsibilities
To assist the Senior CRAs, Quality Manager (QM) and R&D/Governance staff in the partner institutions to ensure that all trials are conducted in accordance with the Medicines for Human Use (Clinical Trial) Regulations 2004 (as amended) and the KHP-CTO SOPs.
• To assist the Quality Manager in the conduct of Regulatory Inspections and sponsor audits on behalf of the partner institutions.
• To provide timely written reports of monitoring activities.
• To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.
• To ensure confidentiality of commercially sensitive information.
• To ensure data protection imperatives are respected.
• To undertake such other duties within the scope of the post as may be requested by the head of department.
To co-monitor and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Monitoring is to be conducted according to Monitoring Plans agreed by the Sponsor institution and the Quality Manager. Activities to include:
- Quality Control of data (Source Document Verification).
- Documentation of protocol violations, adverse events and premature withdrawals.
- Identification and resolution of problems: logistical, methodological, human and technical.
- Detection and reporting of GCP deviations, finding and implementing corrective measures.
- Ensuring timely adverse event reporting including reporting to regulatory authorities on behalf of the sponsor where one or more of the partner institutions is acting as sponsor.
• To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.
• To provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions
• To assist the Senior CRAs and Quality Manager to promote a quality approach to the conduct of clinical trials to all staff involved in the administration and conduct of clinical trials across the partner institutions.
• Assisting the QM and Senior CRAs in collation of metrics and trial data.
• To lead and work flexibly as a member of a team.
• To assist the Clinical Trials Training Executive(s) in the education and training of clinical Investigator teams.
**Essential Criteria: **
**Desired Criteria: **
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