Clinical Trials Feasibility Associate

Job description 

The King’s Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is set up to provide a single interface for those wishing to conduct clinical research within the partner organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.   

 

The Clinical Trials Feasibility Associate (CTFA) is part of a busy team providing an efficient and effective study set-up service for investigators, companies and contract research organisations that are engaging in commercial clinical research within the partner organisations. Members of the team work closely with our research teams and clients to determine the feasibility of proposed commercial projects.  

 

If you have a background in research within Higher Education, currently work in NHS R&D or Clinical Trials Administration in the Pharmaceutical or Allied Health Care and would like to work in a dedicated team with opportunity for career progression, we would like to hear from you.  

 

Candidates will ideally hold a science degree or an equivalent qualification and have experience in setting up clinical trials in the pharmaceutical and allied health industries and/or the NHS/Academic sector. An understanding of the legal, regulatory and statutory governance of clinical trials, or other regulated environments, will be an advantage.   

 

Most importantly, we seek candidates who can think analytically, are confident persuasive communicators who can successfully manage a diverse and very busy workload, largely autonomously. 

 

This post will be offered on an indefinite contract  

 

This is a full-time  post – 100% full time equivalent

 

Key responsibilities

 

-           To conduct and determine the feasibility of proposed commercial clinical research projects across a broad range of therapeutic areas for our partner organisations.  

-          To ensure feasibility assessments are conducted robustly to King’s Health Partner’s SOPs and to develop systems and processes to increase speed and efficiency of the feasibility process. 

-          To work closely with academic, clinical and other staff, at all levels and across the partner organisations, providing appropriate advice and developing effective working relationships to help grow clinical research activity. 

-          To manage the expressions of interest process for commercial trials received from companies, contract research organisations and various research networks Eg. National Institute for Health and Care Research (NIHR) Clinical Research Network. 

-          To communicate effectively with both internal and external partners, giving accurate, clear advice on feasibility and commercial trial pathway 

-          To maintain a working knowledge of prevailing regulations, guidance, best practices and GCP standards regarding the conduct of clinical trials 

-          To ensure internal databases are up-to-date to track trial status and relevant information.  

-          Collate and analyse recruitment performance in the context of feasibility outcomes to inform future feasibility conduct. 

-          Produce and collate feasibility metrics for the Senior Clinical Trials Feasibility Associate. 

-          To keep abreast of relevant current KHP-CTO & NIHR guidance as well as local and national research policy developments. 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.   

Skills, knowledge, and experience 

Essential criteria 

•         Educated to degree level or possess equivalent relevant experience. 

•         Experience of commercial research feasibility and set up within the NHS. 

•         Knowledge, understanding and experience of the legal, regulatory, and statutory governance of clinical trials. Including GCP. 

•         Knowledge of current national systems and structures for the approval, management, and monitoring of clinical research in the NHS. 

•         Ability to analyse and interpret research management information to make sound judgements regarding a range of highly complex research management issues. Problem solving as necessary. 

•         Knowledge of medical, scientific and/ or research terminology 

•         Strong computer skills (proficient with MS Word, Excel and  

Web-based applications). 

•         Excellent organisational and time management skills. A self-starter who can work largely unsupervised 

•         Excellent written and verbal communication skills 

•         Demonstrably high levels of accuracy and attention to detail 

Desirable criteria 

•         Educated at post-graduate level 

•         Excellent interpersonal skills – tactful and being able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations 

•         Experience in the delivery of clinical research within the NHS 

 

Further information

This role is based within the Research Management & Innovation Directorate. The Directorate works in partnership with the academic community to realise the research aspirations of the College. These include: maximising research income, developing researchers, and creating an environment which nurtures world class research and scholarship and delivers a high quality doctoral experience.    

The Research Management & Innovation Directorates provides comprehensive research management and administration through a hub and spokes organisational model. It comprises central functions in the areas of contract negotiation, MTA/CTAs, EU Office, audit and compliance, Graduate School support, College Research Ethics Committee, support to the College Research Committee, and research policy support 

 

About the Department of King’ Health Partners Clinical Trials Office

The Kings Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It has been set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk