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Senior Clinical Research Associate

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£51,974 - £61,021 per annum, including London Weighting Allowance
Closing date
17 Mar 2024

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Job Type
Professional Services
Contract Type
Permanent
Hours
Full Time

Job Details

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 lead a team of Clinical Research Associates/Administrators to ensure GCP compliance (through monitoring) and manage the sponsor responsibilities  of non-commercial trials on behalf of the Partner Organisations who are acting as sponsor or co-sponsor to ensure regulatory compliance. 
  • 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 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 contract.

This is a full-time post - 100% full time equivalent. Part time applications will be considered.

 

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 provide day to day line management of a team of Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs). Activities to include: - 
  1. Reviewing and approving Monitoring Visit Reports 
  2. Advise and assist CRAs, conducting co-monitoring visits as required. 
  3. In discussion with the QM, allocating trials to team members and assessing workload of individuals within the team. 
  4. Assisting KHP-CTO Director and QM with staff recruitment as necessary.  
  5. Set and monitor objectives and foster junior staff development. 
  6. Conduct staff appraisals in line with KCL Policy. 
  • 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 work with other Senior CRAs, CRAs and other staff within KHP-CTO to promote a quality environment and ensure that all trials are conducted in compliance with the regulations and GCP. 
  • To contribute to the day to day management of the KHP-CTO. 
  • To liaise closely with the Partner Trusts’ R&D Departments and Research Management & Innovation Directorate staff within KCL, to ensure compliance with the NHS Research Governance Framework, College policies and contractual obligations for clinical trials are met. 
  • To assist in the prevention, detection and management of clinical research fraud, malpractice and misconduct. 
  • To provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions. 
  • Using a problem solving approach whenever possible. 
  • Assisting the QM in development and implementation of SOPs as required. 
  • Development of trial risk assessments and trial monitoring plans. 
  • Assist trial Investigators with the development and review of clinical trial protocols to ensure quality regulatory compliance. 
  • To prepare and submit Clinical Trials Authorisation Applications to the MHRA. 
  • Assisting the Director and QM 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 trials active staff.  This training to include GCP guidelines, relevant legislation and the research governance framework and to be delivered to staff conducting commercial and non-commercial trials. 
  • To support Investigators and their teams to conduct clinical trials in line with UK   Regulations. 

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  

  1. Educated to degree level preferably in a related subject area, e.g. a life science or clinical subject. 
  2. In depth knowledge of the regulatory requirements for clinical trials and GCP 
  3. 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 
  4. Ability to develop, implement and work to SOPs 
  5. Excellent written and verbal communications skills 
  6. Proven leadership skills and Experience of mentoring or facilitating others  
  7. Excellent organisational and time management skills 
  8. Suitable experience as a Clinical Research Associate gained in the pharmaceutical industry and/or NHS/Academic environments  
  9. Willingness to travel on occasion including overnight stays 
  10. 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

Desirable criteria

  1. Good presentational, organisational, and administrative skills 
  2. Experience of a Regulatory Inspection   
  3. Line management experience 
  4. Experience and knowledge of working within the NHS Research Governance Framework 
  5. Experience of setting up and monitoring clinical trials within the NHS/Academic Sector

Further information

The post will be based in the Research Management Hub within the R&D Department at Guy’s Hospital, Tower Wing. However, it is a requirement of employment that the post holder works at any of the KHP Partner NHS Trusts hospital sites or King’s College London campuses as required to effectively deliver the role and responsibilities.   

As part of our commitment to a progressive working culture, King’s provides opportunities for hybrid working – a mix of on campus and home working: the amount of time that staff are required on site is determined by the needs of their role. 

Appointment within discretionary spine points will be considered based upon experience. 

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
GB

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