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Clinical Research Associate II

King's College London

Location: London
Salary: £43,205 to £50,585 per annum, including London Weighting Allowance dependant on experience.
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 5th February 2024
Closes: 25th February 2024
Job Ref: 083865
 

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.

Skills, knowledge, and experience

Essential criteria  

  • 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 
  • 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 organisational skills including the ability to prioritise, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria
  • 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  
  • 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  
  • Willingness to travel, 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 and closing down 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

Further information

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

Closing date: 25 February 2024 

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