Rachel Shwalb

Research Data Manager Ii @Boston Children's Hospital

Boston, MA, US

Direct data flow for studies supported by the Heart Center. Provide data management support for multicenter clinical research registries. Assist biostatisticians with analysis, file creation and statistical analyses. Provide educational support and training to investigators and study staff for the development and implementation of databases for research studies.ACCOMPLISHMENTS INCLUDE• Successfully managed the months-long collaborative effort with Boston Children’s Hospital CRIT (Clinical Research IT) to migrate the PPHNet Registry, a moderately complex longitudinal database, to a new platform. Worked to migrate the PPHNet database from Medidata Rave to REDCap by recreating the database architecture, providing CRF and field specifications, performing quality assurance testing of the migrated system; and validating the migrated data points by using SAS programming.• Created a database in REDCap for the \'Ozaki Procedure Aortic Valve Registry\'; wrote Study Manual of Operations sections to define database fields; and provided training and mentoring to international, multi-site users of the study database.• Served as a general resource to Heart Center investigators with respect to review of CRFs and database design and with data extraction requests using HC360 data warehouse tool.• Designed a REDCap database for the study, ‘Change in Pediatric Sequential Organ Failure Assessment (pSOFA) Score as a Clinical Trial Endpoint for Pediatric ECMO Research’. Worked with the Project Manager to develop the Case Report Forms (CRFs). • Wrote a complex SAS program to calculate pSOFA scores.• Used SAS to validate data migrated from SPSS to REDCap for the study, ‘Standardized Outcomes of Reproductive Cardiovascular Care’ (STORCC).• Used the FDA-compliant OpenClinica clinical trials data management system to provide support to the data manager for the ‘TITRE (Trial of Indication-Based Transfusion of Red Blood Cells in ECMO)’ registry.

Northeastern University

MSIS

Harvard University Graduate School of Education

Masters in Education

Barnard College

B.A.