Start-up Specialist - London, United Kingdom - Thornshaw Scientific Recruitment

Tom O´Connor

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Tom O´Connor

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Description
Posted date 23 March 202- LocationLondon

  • Job type Contract
  • SalaryNegotiable
  • Discipline Life Sciences
  • ReferenceJO
  • Work Location Hybrid
Start-up Specialist


Contract length - initially 3 months


Rate - £35k-£40k hosted DOE


Location - London (hybrid)


Start date - ASAP


Responsibilities:


  • Be familiar with the regulatory and ethics requirements for the conduct of clinical research (Research Governance Framework, ICH-GCP, and the processes of HRA)
  • Be responsible for obtaining permissions and local approvals with relevant departments
  • Liaise with investigators to ensure sufficient capacity and resources for new projects
  • Take lead, coordinate, and track the timely completion of Feasibility and Expression of Interest
  • Coordinate setup meetings and Site Initiation Visits (SIVs)
  • Be responsible for creating Investigator Site File (ISF) and for the setup of trials on the EDGE Research Management System
  • Help to determine timelines for study to setup
  • Upon completion of site activation, provide accurate and concise handover
  • Communicate effectively with relevant stakeholders
  • Act as a key point of contact for the University with sponsor sites (Pharma, CRO & other universities)
  • Ensure any queries and questions are dealt with effectively
  • Schedule and coordinate documentation for the portfolio review meetings
  • Collate data for annual reports, monthly reviews of accrual data etc.

Required:


  • Demonstrable experience using Clinical Trial Research Management software e.g., EDGE
  • Previously used or understand how to use Integrated Research Application System (IRAS)
  • Understanding of ICH-GCP

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