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.