Clinical Research

develop and write trial protocols (outlining purpose and methodology)
present trial protocols to a steering committee
design data collection forms, known as case report forms (CRFs)
coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
identify and assess the suitability of facilities to use as the clinical trial site
identify/select an investigator who will be responsible for conducting the trial at the trial site
liaise with doctors, consultants or investigators on conducting the trial
set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
train the site staff to trial-specific industry standards
monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
collect completed CRFs from hospitals and general practices
write visit reports and file and collate trial documentation and reports
meet with team members to discuss on-going trials, results and any trends or adverse events
ensure all unused trial supplies are accounted for
close down trial sites on completion of the trial
discuss results with a medical statistician, who writes technical trial reports
archive study documentation and correspondence
prepare final reports and occasionally manuscripts for publication.