Dec 20, 2017
Jan 19, 2018
Ellis Simmonds
Contract Type
Full Time


This major CRO provides monitors with world class technology, training resources, and limited protocol load. You will also be rewarded for your hard work through our CRA bonus incentive program and career advancement opportunities.

Your Key Accountabilities:
  • Perform all clinical monitoring/site management activities for assigned projects in accordance with standard operating procedures
  • Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
  • Function as a mentor and role model for other CRA team members
  • Provide study specific training for CRAs acting as a lead CRA on individual projects
  • Establish site recruitment plan in collaboration with site during qualification visit; follow-up and update at initiation visit and monitoring visit
  • Attend external client meetings and presentations including investigator meetings and professional conferences
  • Manage clinical monitoring activities, including:
  • Arranging on-site visits and logistics
  • Establishment of a site recruitment plan in collaboration with site staff during QV
  • Monitoring completeness and quality of Regulatory Documentation
  • Performing site documentation verification
  • Data collection and drug accountability in accordance with ICH GCP guideline
  • Monitoring patient safety on-site and addressing any violations in a timely manner
Your Skill set:
  • Substantial monitoring experience in clinical research/Clinical Research Organisations
  • Educated to degree level (biological science, pharmacy or other health related discipline)
  • Strong working knowledge of EDC systems and IVRS
  • Solid understanding of therapeutic indications and study protocol
  • Ability to lead a "virtual" team
  • Competent in written and oral English and Dutch, with a conversational level of French, or fluency in French, with a conversational level in Dutch

Hydrogen UK Limited is acting as an Employment Business in relation to this vacancy.