Clinical Research Associate II 

Job ID: 011287

Salary: Salary: £ 38,304 to £45,026, including London Weighting Allowance

Posted: 04-Dec-2020

Closing date: 03-Jan-2021

Business unit: Research Platforms

Department: KHP Clinical Trials Office

Contact details: Hannah Mason, Hannah.Mason@kcl.ac.uk

Guy's Campus   Professional and support services    
 
Job description

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

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. Also to assist Chief Investigators with the set up and initiation of their trials and to ensure that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations

The post holder will be required to:

• To set up and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance.
• To provide support to investigators conducting clinical trials sponsored by King’s Health Partners Organisations to ensure they are working to the highest quality standards and to monitor and report on the progress of trials across the partner institutions where one or more of the partners is acting as sponsor or co-sponsor.
• The post holder will ensure that investigators and their teams run trials 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 Quality Manager (QM) and R&D staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the current UK and EU Clinical Trial legislations and the KHP-CTO SOPs.
• To ensure that development safety update reports, pharmacovigilance reports and protocol amendments are submitted to the MHRA thereby maintaining Clinical Trials Authorisations.
• To set up, initiate and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Monitoring to be conducted according to Monitoring Plans agreed by the Sponsor institution and the Quality Manager.
• To assist the Quality Manager in the conduct of Regulatory Inspections and sponsor audits for both commercially sponsored and non-commercially sponsored trials on behalf of the partner institutions.
• 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 and to ensure data protection imperatives are respected.
• To act as an ambassador for the KHP-CTO.
• To visit investigators and their trial teams across the partner institutions to support them in the conduct of high-quality commercial clinical trials by providing advice and practical assistance such that our trialists represent an attractive proposition for commercial sponsors.
• To liaise closely with the Trust R&D Departments and College Research Grants and Contracts teams to ensure compliance with the NHS Research Governance Framework and   contractual obligations for clinical trials are met.
• To document and track communication with trial sites.
• To 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:
• Review of trial progress and reporting to the sponsor.
• 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. 
• Management of trial related logistics.
• 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. 
• This post is home-based on with both national and international travel on occasion including overnight stays 

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 “A” level or degree level, preferably in a related subject area, e.g. a life science or clinical subject  
• Sound working knowledge of the prevailing regulations and best research practices pertaining to the conduct of clinical trials, in particular GCP  
• Strong planning and organizational skills including the ability to prioritize, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria. 
• Strong interpersonal, communication, influential and problem solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment 
• Strong computer skills (proficient with MS WORD, Excel and web-based applications). 
• Eye for detail and ability to accurately document findings in written reports 
• Able to learn and work to SOPs and demonstrate a commitment to quality culture  
• Monitoring of clinical trials to GCP in pharmaceutical company, contract research organisation, NHS or academic setting for at least 12 months 
• Willingness to travel on occasion including overnight stays  

Desirable criteria 

• Experience across a range of therapeutic areas 
• Experience and knowledge of working within the NHS Research Governance Framework. 
• Experience of 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 academic, NHS and business managers in industry. 
• Strong Team Player