Maureen Patrick, Ccrc Email & Phone Number

Performed remote patient data and site level review activities for three Phase II and III oncology studies and one Women’s Study to assess compliance with the protocol, ICH-GCP and local regulatory requirements.Critically evaluated and identified trends and issues by analyzing the Central Monitoring Clinical Review Dashboard and Key Risk Indicator Dashboard.Responsible for reviewing data for informed consent, subject eligibility, Adverse Events, Serious Adverse Events, safety reporting, critical data issues and trends, significant errors or data integrity risk and trends along with site process issues, subject level deviations, site level non-compliance, action items and data queries.Wrote and issued queries, created action items, and recorded protocol deviations in appropriate databases for action by sites and CRAs. Documented and summarized findings, observations and trends in a Site Central Assessment Notification Report for CRAs to develop an Action Plan and prioritize on-site monitoring.Reviewed query responses and associated actions entered in the EDC by site personnel to confirm appropriate response/closure.Communicated to CRAs and followed appropriate escalation pathways per CMP if a finding noted during Central Monitoring review was considered to have a significant impact on subject safety, data integrity or regulatory compliance.Provided training for new central monitors on how to perform central monitoring reviews and write a Site Central Assessment Notification Report.Demonstrated flexibility and team work by helping other teammates and projects during down time.

Regional- Northeast

Successfully completed Part I of the Accredited Clinical Research Monitor Program provided by The International Academy of Clinical Research through the Clinical Trials Institute twelve week program at INC Research.Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects.Ensured identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.Conducted Site Initiation Visits, Pre-Study Selection Visits and Interim Monitoring Visits.Performed monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.Reviewed accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).Ensured accountability of Investigational Product and related supplies.Executed complete reporting and proper documentation of monitoring activities.Conducted routine monitoring visits (on site or remotely) independently from the investigative site study staff.Confirmed the sites are identifying issues and implementing corrective and preventive actions to ensure inspection readiness.

Dana-Farber Cancer Institute at Milford Regional Medical Center 01/ 9 – 05/17CLINICAL RESEARCH COORDINATOR, MEDICAL ONCOLOGYAssists and coordinates enrolling patients onto clinical trials through screening, registration, education, and follow up of eligible subjects according to protocol requirements. Collaborated with research RN and developed workflows for newly developed cancer research program at satellite locationImplemented study–specific communications and education for site staffResponsible for timely and accurate data reporting, collection of source documents, adverse event reporting, filing and archiving of study records and resolution of data queriesParticipated in routine monitoring visits with sponsors and responds to any findingsCollected, packed, logged and shipped biologic specimens when applicableEnsured compliance with protocol guidelines and requirements of regulatory agencies