Maintained knowledge of and recorded adverse events. Entered data into spreadsheets and utilized PDMS system to enter information regarding adverse events on active protocols. Additionally, entered data into PDOL and CORe systems. Reviewed adverse events reports to determine if escalation to senior management was necessary. Participated in Site Initiation Visits (SIVs), conference calls and protocol meetings. Addressed backlog of adverse event reporting and brought department current in reporting. Discovered advere events that would affect patients on active studies at MD Anderson and escalated to management. Tracked and managed all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures. Updated department website and uploaded current information regarding adverse events. Communicated effectively verbally and in writing, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration). Prepared reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually). Coordinated with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations. Coordinated and participated in monitoring visits and internal or external audits to ensure objectives were met. Applied knowledge and experience when addressing study issues, gathering relevant information systematically and making sound decisions. Acted as a liaison with research team as well as other institutions, agencies and initiates, developed, and managed relationships and networks. Worked in situations involving uncertainty, shifting priorities and rapid change dealing constructively with mistakes and setbacks and demonstrating flexibility. Assisted with responsibilities and activities within the coordinators' office in accordance with individual strengths and expertise. Maintained a high level of professional expertise and credibility through educational programs, including on-site training. Participated in continuing education including maintaining familiarity with the clinicaltrials.gov site as a means of monitoring protocols and entering pertinent data into the system.