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Clinical Research Associate

Keyrus Biopharma

Home Based, United Kingdom

Job Description

To reinforce our Clinical Development Business unit, Clinical Operations department, we are looking for an experienced Home-Based CRA for UK.

Main duties

  • Ensuring all aspects of study site monitoring visits both covering United Kingdom sites (selection, initiation, monitoring and close-out) according to Keyrus Biopharma or Client SOPs;
  • Writing of study site visit reports;
  • Maintenance of study files and administrative follow-up of studies according to GCP-ICH;
  • Participation in the preparation of submissions to ECs;
  • Ensuring, in compliance with GCP and SOPs, the quality, reliability and authenticity of data collected during monitoring;
  • Review clinical sites progress and initiate appropriate actions to achieve target recruitment objectives.

Profile

  • University Scientific Degree, Master: Biology, Bio Medical Sciences, Bio Engineer or equivalent by experience;
  • Good knowledge ICH-GCP/GMP and regulatory requirements;
  • Attention to detail;
  • Analytical and organized;
  • Good interpersonal skills;
  • Good oral and written communication;
  • Native English Speaker, other European language is a plus.

Required work experience in this role

  • 2-3 years experience in a pharmaceutical company or CRO with experience of clinical monitoring.

For more details and to apply for this job click here

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