Ergomed is a successful, growing international company with our HQ in the UK and offices worldwide.  We offer our employees a genuine opportunity to work in an environment that offers challenges, prospects for progression and is one which recognises achievement.

Position summary: 

At Ergomed our monitors ensure each study is being conducted according to the study protocol and in line with the principles of Good Clinical Practice.

 

The duties and responsibilities of the Monitor II are to:

  • Verify that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s), and report any deviation as per study procedure
  • Verify that the rights and well-being of the human subjects, the clinical study’s participants, are protected and to conduct monitoring to confirm subject safety and data integrity
  • Identify the investigators and verify that the investigators have adequate qualifications and resources, and in addition to ensure that the facilities, including the laboratories, equipment and staff are adequate in order to safely and properly conduct the clinical study throughout the study period
  • Act as the main point of communication with the Investigator and their team
  • When requested, support preparation of the regulatory and/or EC submission
  • Be able to review the Master ICF version and prepare the appropriate local ICF
  • Coordinate document translation, verification and back translation where required
  • Ensure timely submission of protocol/consent/safety reports documents for ethics/IRB approval
  • Verify the correct storage of drugs and the diligent accounting of all drugs in accordance with the study procedures
  • Verify investigational medicinal product/device and other study materials tracking
  • Maintain all files and documentation pertaining to studies
  • Perform regular QC of the Trial Master Files – for country(ies) and sites being responsible for monitoring
  • Motivate investigators in order to achieve recruitment targets
  • Keep the PM and/or CTM regularly informed and complete accurate study status reports
  • Process case record forms to the required quality standards and timelines (SOP PM 014)
  • Deal with Sponsor-generated queries in a timely manner
  • Participate in feasibility studies for new proposals, as required
  • Ensure the satisfactory close-out of investigator sites
  • Act in the Lead role on the study, assuming additional responsibilities as directed by the PM/CTM/PD, if appropriate
  • Ensure the correct archiving of files on the completion of a study
  • Maintain patient and sponsor confidentiality
  • Develop, review and revise Ergomed’s SOPs within the area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards/requirements
  • Participate in the mentoring/training of new staff, as well as performing co-monitoring visits to assess junior staff performance

If this role is of interest, we invite you to send your CV to careers@ergomedplc.com