Fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual (if applicable), supporting documents, procedures, and timelines to enable day to day running of the trial including all relevant SOPs. Ensure the accurate reporting of adverse events (AEs) and serious adverse events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) to the site team and relevant RNPM, providing support for any additional follow-up that may be required.