1 Good Clinical Practice Jobs in the East Midlands

of documentation for Ethical Approval and the NIHR CSP and EDGE process To establish trial site files for each trial in accordance with ICH-GCP and research governance. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol … Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries Have a solid understanding of … the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes Ensure safety data is reported to required more »