Michelle G.

Experience

1. Clinical Research Data Specialist

   Mass General Brigham

   Jan 2023 — Present

   The Cancer Center Protocol Office at Massachusetts General Hospital provides clinical and administrative support to Principal Investigators to conduct therapeutic Oncology clinical trials in various disease groups. As a Clinical Research Data Specialist, I performed data management tasks for industry sponsored, cooperative group, and investigator initiated clinical trials within the cancer center.• Obtained and abstracted complex clinical data from various sources including electronic medical records, research documents, and communications with Principal Investigators for Phase Oncology studies in both solid tumor and hematology disease groups• Entered data into electronic Case Report Forms within study specific databases in a timely manner to ensure that the study sponsor had a real time view of safety and other study endpoint data• Performed quality control to identify data discrepancies, protocol deviations, and missing information and maintained trackers to ensure these were monitored to resolution• Answered queries and communicated with sponsor representatives to correct Case Report Forms, and ensure the transmittal of high quality data to be used for analysis for submission to the FDA for approval of novel therapies

Education

• Rutgers University–New Brunswick

  Bachelor of Science - BS, Public Health