Senior Clinical Trials Coordinator – Internal Only

THIS VACANCY IS OPEN TO INTERNAL APPLICANTS ONLY

The role of the Senior Clinical Trials Coordinator is to manage the day-to-day running of clinical study and trial activity for the King’s Clinical Trials Group, Centre for Rheumatic Diseases, Denmark Hill site, to ensure compliance with all applicable trial regulations, study protocols, and where applicable, clinical trials agreements.  Emphasis is placed on those studies where no study specific coordinator or trial manager has been assigned. During the pandemic, the remit of the centre has been extended to include COVID-19 studies, including treatment and vaccine trials, and biomarker studies.    

The role includes supervising and supporting the activity of Research Nurses, Clinical Research Practitioners and Administrators working to deliver on these studies at Kings College Hospital, with support from the Centre Clinical Studies Manager who works across campuses.  Further key roles of the Senior Clinical Trials Coordinator will be to support the implementation of recruitment strategies to ensure the successful delivery of the centre portfolio and to play an active role in the delivery of commercial and non-commercial research studies, where applicable acting as the primary coordination contact for study sponsors.

 The Senior Clinical Trials Coordinator will also support the Centre Clinical Studies Manager with the management of Kings College Hospital financial accounts including monitoring of trial related income, and in the case of non-commercial income raising invoices. Additional support for data management may be required, primarily to review and delegate tasks to more junior team members. 

The post will be based at Denmark Hill working with the King’s College Hospital team. Occasional support for the Guy’s Hospital team may be required but may be delivered from the KCH site. Some support may also be required for patient facing clinical research activity. 

This post will be offered on a a fixed-term contract for 12 months 

This is a full-time post

•       Implementing and maintaining efficient and responsive administrative systems to ensure the smooth and effective conduct of clinical studies   

•       Supporting the implementation of effective recruitment strategies to ensure accurate prediction of patient numbers to enable successful delivery of studies within the portfolio 

•       Delegation and supervision of administrative tasks to team administrators   

•       Ensuring that all of the required documentation and appropriate regulatory approvals are in place for studies to start 

•       Ensuring that staff due to work on studies understand the protocol and regulatory requirements and are suitably trained, including maintenance of the Denmark Hill research team training records 

•       Monitoring and maintaining the departmental email accounts, actioning emails or referring them to other staff as appropriate. 

•       Raising financial invoices according to the relevant Clinical Trial Agreement (CTA) and trial activity to ensure income is received from Sponsor, and supporting the Centre Clinical Studies Manager with any other financial activity as required e.g. regular account review to ensure the continued smooth running of the centre’s research activity  

•       Acting as the key coordination contact for sponsor representatives including Clinical Research Organisations and academic sponsors 

•       Regular review of study data and implementation of effective strategies where required to improve the standard of data collection and/or entry 

•       Monitoring and updating recruitment figures on all relevant systems in a timely fashion to ensure data is correct and the correct income is directed to the team  

•       Review, cataloguing and dissemination of applicable amendments to study protocols to wider study teams, including coordination of any necessary changes to documentation or resource required to deliver the study  

•       Support for the preparation and submission of amendments for KCL sponsored studies where applicable 

•       Delivery of training to study site staff as appropriate, to ensure protocol compliance 

•       Contribution to stakeholder reports together with the Centre Clinical Studies Manager e.g. annual REC reports or in response to CRO or funders   

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.  

Essential criteria  

1.       Postgraduate qualification in clinical trials or a relevant field OR educated to degree level with substantial clinical trials research experience and willingness to engage in a further qualification  

2.       Experience with rheumatic disease and/or immune mediated inflammatory disease 

3.       Experience coordinating research studies in a hospital setting 

4.       Experience of handling data 

5.       Knowledge of ICH, GCP, R&D governance and EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004  

6.       Experience of working effectively within a multi-disciplinary research team 

7.       Experience working across both commercial and non-commercial research studies and knowledge of the differences in study delivery and management 

8.       Competent in use of Microsoft office including excel, word and outlook 

9.       Competent in use of electronic data capture systems e.g. medidata RAVE/MACRO or equivalent 

10.   Knowledge of sample management 

Desirable criteria

1.       Familiar with IRAS applications 

2.       Experience with invoicing 

3.       Experience of supervision of more junior team members