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Clinical Research Associate II

Employer
KINGS COLLEGE LONDON
Location
London (Central), London (Greater)
Salary
£43,205 - £50,585 per annum, including London Weighting Allowance
Closing date
4 Feb 2025

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Job Details

Job description

If you are an experienced CRA, we would like to hear from you. 

We are looking for an experienced monitor; the successful applicant will have experience of working independently at sites, performing source data verification and monitoring trials to GCP. 

This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations; therefore, the university will not be able to offer sponsorship for this role.

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. The team assists Chief Investigators with the set-up, initiation, maintenance and closure of their trials and ensures that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations.

The post holder will be required to: 

  • Set up, monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance. 
  • Provide support to investigators conducting clinical trials sponsored by partner institutions to ensure they are working to the highest quality standards and to monitor and report on the progress of trials. 
  • 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 a fixed-term contract for 12 months for a Maternity Leave Cover.

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 MHRA, thereby maintaining Clinical Trial Authorisations 

-  To set up, initiate, monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Activities to include: 

  • Review of trial progress and reporting to the sponsor. 
  • Quality Control of data (Source Document Verification). 
  • Documentation of protocol violations/deviations, 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. 
  • Documenting and tracking communication with trial sites. 

-  To assist the QM 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 provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions. 

-  To promote a quality approach to the conduct of clinical trials and act as an ambassador for the KHP-CTO

-  This post is field based with regular national and, on occasion, international travel 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  

  1. Significant experience of monitoring of clinical trials to GCP (including source data verification) OR significant experience in CTIMP trial management of multi-centre studies in a pharmaceutical company, contract research organisation, NHS or academic setting 
  2. Educated to “A” level or degree level, preferably in a related subject area, e.g. a life science or clinical subject  
  3. Sound working knowledge of the prevailing regulations and best research practices pertaining to the conduct of clinical trials, in particular GCP  
  4. Strong planning and organisational skills including the ability to prioritise, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria. 
  5. Strong interpersonal, communication, influencing and problem-solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment  
  6. Strong computer skills (proficient with MS WORD, Excel and web-based applications). 
  7. Eye for detail and ability to accurately document findings in written reports 
  8. Able to learn and work to SOPs and demonstrate a commitment to quality culture  
  9. Willingness to travel, including overnight stays  

Desirable criteria

  1. Experience across a range of therapeutic areas 
  2. Experience and knowledge of working within the NHS Research Governance Framework. 
  3. Experience of setting up and closing down clinical trials within the NHS/academic sector or within a pharmaceutical company 
  4. Ability to understand and function in the different cultural environments of clinical research

  Further information

Successful candidates are expected to be based within a reasonable travel distance to London.

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
United Kingdom

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