Stephine Marie Wasielewski, BA, CCRP

Stephine Wasielewski, BA, CCRP


Stephine Wasielewski, BA, CCRP is a clinical research professional and data scientist with over 20 years of experience working with phase 1-3, multi-site oncology clinical trials and has expertise in trial management and operations, data management and reporting, regulatory compliance and quality assurance, biospecimen management, and education and training on international and federal regulations.

 

Throughout this time, Stephine has served as a Subject Matter Expert (SME) for IT and informatics teams and has led multiple projects including the implementation and management of Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC) systems; the integration of Epic’s Electronic Medical Records (EMR); the creation of data standards and queries systems aligned with Common Data Elements (CDE) and data models; and the harmonization of clinical research practices involving research groups, hospital units, sponsors, vendors, and external sites resulting in improved patient safety, study timelines, data accuracy, and budget/billing compliance across the entire clinical trials portfolio.


Stephine is a results-oriented leader with an academic foundation, strong knowledge of industry and federal practices, and a proven track record for designing successful clinical research programs, processes, and IT-related solutions that increase the efficiency and integrity of clinical trials.


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