Rhiannan Minton

Supporting the company’s clinical operations function in the management of the FDA. Works directly with the study team, vendors, and clinical study sites to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/CFR regulatory guidelines, as well as in line with company goals, timelines, and budgets. Provides input, necessary support, and oversight for the high-quality execution of global clinical trials. Supplies support for documentation of important clinical trial data, site start-up, and other operational information to ensure a successful clinical trial.

• Manages and monitors assigned study sites and networks, conducting protocols according to the monitoring plan. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc. Responsible for delivering data within timelines and required quality standard and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible for training study site personnel.

• Lead CRA responsibilities to drive the management of key programs. Takes on the responsibility as SME (Subject Matter Expert), as needed. Conducts Quality Visits with assigned CRAs at selected sites to ensure site and monitoring processes are up to GCP, Protocol and quality standards. Oversight of CRO CRAs as main point of contact for trial and Sponsor questions. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc., according to the monitoring plan. Responsible for delivering data within timelines and required quality standards and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible for training study site personnel and new CRAs.

• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST). Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents, recruitment material, monitoring tools. Supports and contributes to Clinical Study Teams agenda driven, present at meetings. Communicates country status (including timelines and deliverables) to key stakeholders with oversight as required and ensures updates to relevant systems. Delivers CRA, Investigator and Study Coordinator training as required. Responsible for monitoring of applicable vendor activities. Responsible for Enrolment Plans at Country Level. Monitors the execution of the clinical study against timelines, deliverables, and budget for the US. Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate. Monitors and reviews country and study trends. Reviews Monitoring Visit Reports. Identifies and facilitates resolution of cross-functional study-specific issues. Escalates any issues related to delivery, timelines, or budget to senior management. Escalates CRA performance issues to applicable Clinical Trial Oversight Manager. Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.

• Manages and monitors assigned study sites and networks, conducting protocols according to the monitoring plan. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc. Responsible to deliver data within timelines and required quality standard and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible to train study site personnel.

• Manages and monitors assigned study sites and networks, conducting protocols according to the monitoring plan. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc. Responsible to deliver data within timelines and required quality standard and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible to train study site personnel.

• Manages and monitors assigned study sites and networks, conducting protocols according to the monitoring plan. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc. Responsible to deliver data within timelines and required quality standard and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible to train study site personnel.

• Senior, CRA
• CRA III May 2009-Feb 2013
• CRA II Jul 2008-May 2009
• CRA I May 2007-Jul 2008
• CRA I Feb 2006-May 2007
• Manages and monitors assigned study sites and networks, conducting protocols according to the monitoring plan. Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, laboratory abnormalities, etc. Responsible to deliver data within timelines and required quality standard and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs. Responsible to train study site personnel.