The King’s Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between King’s Health Partners member institutions. It was set up to provide a single interface for those wishing to conduct clinical trials within partner institutions and to ensure that there are common and efficient processes for setting up and administering clinical trials. . http://www.khpcto.co.uk
The KHP-CTO Quality Team was established in 2008 to manage the Clinical Trials of Investigational Medicines (CTIMP) sponsorship responsibilities, as defined in the Human Medicines (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organizations. The team assists lead investigators in setting up and launching their trials and ensures that these trials are established and conducted in accordance with good clinical practice (GCP) and regulations.
We are looking for an experienced instructor; the successful candidate will have experience working independently on sites, performing source data audits and monitoring testing for GCP.
The job holder will be required to:
- Set up and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions act as sponsor, to ensure regulatory compliance.
- Provide support to researchers conducting clinical trials sponsored by partner institutions to ensure they are working to the highest quality standards and to monitor and report on trial progress.
- Ensure that investigators and their teams conduct trials in accordance with sponsor SOPs, applicable regulations, and best research practices by providing guidance, hands-on assistance, and performing oversight functions as appropriate.
If you are an experienced CRA, we would love to hear from you.
This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations and therefore the university will not be able to offer sponsorship for this role.
We have three positions available, and these are:
– 2 x CDI
– 1 x maternity cover up to 12 months
All positions are full time 35 hours per week .
- Assist the Quality Manager (QM) and R&D staff of partner institutions to ensure that all trials sponsored or co-sponsored by partner organizations are conducted in accordance with current UK and EU clinical trial legislation and KHP- SOPs CTO.
- Ensure development safety update reports, pharmacovigilance reports and protocol changes are submitted to the MHRA thereby maintaining clinical trial authorizations
- Set up, initiate and monitor clinical trials on behalf of the sponsor when one or more of the partner institutions act as sponsor. Activities to include:
- Review of trial progress and report to sponsor.
- Data quality control (verification of source documents).
- Documentation of protocol violations, adverse events and premature withdrawals.
- Identification and resolution of problems: logistical, methodological, human and technical.
- Management of the logistics related to the tests.
- Detection and reporting of GCP deviations, research and implementation of corrective measures.
- Ensure timely notification of adverse events, including notification to regulatory authorities on behalf of the sponsor when one or more of the partner institutions act as sponsor.
- Document and track communication with trial sites.
- Assist the MQ in conducting regulatory inspections and sponsorship audits for commercially sponsored and non-sponsored trials on behalf of partner institutions.
- Maintain a working knowledge of applicable regulations, guidelines, best practices and clinical QA standards regarding the conduct of clinical trials.
- Provide advice on GCPs and related issues to those wishing to conduct clinical trials at partner institutions.
- Promote a quality approach in the conduct of clinical trials and act as an ambassador for the KHP-CTO
- This position is field based with occasional domestic and international travel including overnight stays
The above list of responsibilities may not be exhaustive and the post holder will be required to undertake the duties and responsibilities reasonably expected within the scope and classification of the post.
Skills, knowledge and experience
- Significant experience in GCP clinical trial oversight (including source data verification) OR significant experience in CTIMP trial management of multicenter studies; in a pharmaceutical company, contract research organisation, the NHS or an academic institution
- Graduated to ‘A’ level or University level, preferably in a related field, e.g. a life science or clinical subject
- Good working knowledge of applicable regulations and research best practices relating to the conduct of clinical trials, particularly GCPs
- Strong planning and organizational skills, including the ability to set priorities, manage multiple tasks and projects, with a proven ability to meet rigorous performance criteria.
- Strong interpersonal, communication, influencing and problem-solving skills, including the ability to build successful relationships and collaborate within a cross-functional team and maintain a positive work environment
- Strong computer skills (proficiency in MS WORD, Excel and web applications).
- Attention to detail and ability to accurately document findings in written reports
- Able to learn and work according to SOPs and demonstrate commitment to quality culture
- Willingness to travel, including occasional overnight stays
- Experience in various therapeutic areas
- Experience and knowledge of working within the NHS research governance framework.
- Experience setting up clinical trials within the NHS/academic sector or within a pharmaceutical company
- Ability to understand and function in the different cultural environments of clinical research
Successful applicants must be based within a reasonable distance of London.