advice on best practice at all stages of the trial. The post-holder promotes quality and compliance by engaging with research teams in a positive manner through trainings, workshops and ad hoc meetings. The role is an essential link between activities in the field/trial site and the sponsor’s office. Where MRCG acts as clinical trial sponsor, the Clinical Trial Monitor supports delivering appropriate sponsor oversight. Where MRCG is not the sponsor the clinical trial monitor supports the investigator in meeting local regulatory and MRCG requirements. Key Responsibilities: Clinical trial monitoring Support development of risk-based monitoring plan Conduct site initiation visits, interim visits and close-out visits Provide on-site monitoring according to the clinical trial protocol, monitoring plan and MRCG procedures Review informed consent process and documentation at trial site Review source data, SAE and all trial related documentation for accuracy, contemporaneity and completeness Positively and effectively communicate and discuss monitoring findings with investigator teams Facilitate the development and implementation of corrective action plans Prepare accurate and timely monitoring reports and follow-up letters Follow-up issues and corrective actions consistently, effectively and timely Proactively engage research teams to pre-emptively identify and address areas of concern Deliver a range of remote monitoring activities, including review of trial data Critically review monitoring reports for trials monitored by external parties Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for treatment and informed consent and other areas Confirm investigational products are handled, stored and used in line with the protocol and Unit SOPs Ensure samples and records are stored appropriately with adequate environment controls. Clinical trial support Act as focal point for communication with the trial team for MRCG sponsored trials and contact site staff regularly Register clinical trials on public databases and update entries, as required Record SAE reports and notify regulatory authority and sponsor and ensure events are followed-up appropriately by the investigator Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for MRCG-sponsored trials, as applicable Advise trial teams on latest changes in regulatory environment and international guidelines Oversee that MRC-sponsored studies are well managed and delivered to expected timelines
advice on best practice at all stages of the trial. The post-holder promotes quality and compliance by engaging with research teams in a positive manner through trainings, workshops and ad hoc meetings. The role is an essential link between activities in the field/trial site and the sponsor’s office. Where MRCG acts as clinical trial sponsor, the Clinical Trial Monitor supports delivering appropriate sponsor oversight. Where MRCG is not the sponsor the clinical trial monitor supports the investigator in meeting local regulatory and MRCG requirements. Key Responsibilities: Clinical trial monitoring Support development of risk-based monitoring plan Conduct site initiation visits, interim visits and close-out visits Provide on-site monitoring according to the clinical trial protocol, monitoring plan and MRCG procedures Review informed consent process and documentation at trial site Review source data, SAE and all trial related documentation for accuracy, contemporaneity and completeness Positively and effectively communicate and discuss monitoring findings with investigator teams Facilitate the development and implementation of corrective action plans Prepare accurate and timely monitoring reports and follow-up letters Follow-up issues and corrective actions consistently, effectively and timely Proactively engage research teams to pre-emptively identify and address areas of concern Deliver a range of remote monitoring activities, including review of trial data Critically review monitoring reports for trials monitored by external parties Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for treatment and informed consent and other areas Confirm investigational products are handled, stored and used in line with the protocol and Unit SOPs Ensure samples and records are stored appropriately with adequate environment controls. Clinical trial support Act as focal point for communication with the trial team for MRCG sponsored trials and contact site staff regularly Register clinical trials on public databases and update entries, as required Record SAE reports and notify regulatory authority and sponsor and ensure events are followed-up appropriately by the investigator Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for MRCG-sponsored trials, as applicable Advise trial teams on latest changes in regulatory environment and international guidelines Oversee that MRC-sponsored studies are well managed and delivered to expected timelines