This vacancy is now closed

Clinical Research Associate - London

car allowance, pension, healthcare - Clinical Operations - Clinical Research General
Ref: 1053 Date Posted: Monday 16 Jul 2018
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Entrust People are working with an exciting mid sized CRO company who are specialising in oncology, CNS & Medical device trials these roles are looking to hire in the London area to help build out more depth within this clinical group within a world-leading full-service clinical research organisation (CRO).
Essential duties and responsibilities include, but are not limited to the following:
  • Conducts and documents Pre-Study Visits (PSVs), Study Initiation Visits (SIVs)/Qualification Visits (QVs), Monitoring Visits (MV) and Closedown Visits (CV)
  • To monitor and report on Investigators adherence to approved protocol/amendments and on study conduct at each study site 
  • To ensure that the Investigator maintains all essential documents and that study related documents, including but not limited to source documents and case report forms, are complete and accurate 
  • To assist with feasibility studies 
  • Manage timely compilation and submission of Ethics Applications and assist in Regulatory applications where required 
  • Conduct telephone calls to investigator sites to evaluate potential patient eligibility and enrolment, and to follow-up on any outstanding issues 
  • Assist with investigator meetings through the preparation, assembly and shipment of training materials 
  • Co-ordinate the collection of essential documentation in accordance with ICH/GCP 
  • Identify, document and report SAEs according to ICH/GCP guidelines and local regulatory requirements, within required timelines and follow-up as required 
  • Conduct final IMP reconciliation, and arrange return of unused IMPs to the sponsor 
  • Be responsible for monitoring and maintaining IMP accountability at investigator sites 
  • Prepare site visit reports and status reports, document site actions in follow up letters/email 
  • Take telephone calls from team members, investigators and sponsor.
  • Document and followup these calls 
  • Assist Project Manager/CRA Manager with establishing and implementing the query resolution process 
  • Gain an in-depth understanding of the study protocol, CRF and related procedures 
  • Develop good working relationships with investigator site personnel and provide support, training and motivation
The role will require you to be educated to degree level or equivalent in a scientific field with proven CRA experience, preferably within a CRO or a pharma company; a full driving licence together with a willingness to travel. The role requires:
  • A very strong understanding of the clinical process (particularly Phase II & III) and the ramifications of change to one or more study assumptions including timeline.
  • Previous proposal experience is preferred 
  • Excellent planning/organizational skills and ability to prioritise and multitask 
  • Ability to develop effective cross-functional relationships 
  • Results orientated 
  • Excellent communication, relationship building and interpersonal skills 
  • Able to work with autonomy 
  • Ability to order and prioritise tasks 
  • Computer Literacy (Word, Excel, PowerPoint, Outlook Express) 
  • Numeric and budgeting skills 
  • Good attention to detail
 This is an exceptional opportunity within a career driven and progressive organisation offering excellent salaries and benefits.
 KEY WORDS: Clinical Research Associate; CRA; ICH GCP; Monitor; Monitoring
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