Wendy Schroeder

Clinical Trial & Clinical Research Compliance.

Wendy is a registered nurse by profession and a consultant for Schroeder Clinical Research Consulting, LLC. In addition to 14 years of bedside nursing with Cardiology and Oncology expertise, she has over 20 years of clinical trials experience in varying roles including research operations, regulatory oversight and clinical trial billing.

Wendy has worked with coverage analysis and clinical trial billing subject matter experts and is recognized as an authority in process development and documentation to mitigate billing risk and optimize business investment in research and clinical trials. During the course of her career Wendy filled key research operational and leadership roles in a variety of settings including clinics, nonprofit hospitals, for profit diagnostic laboratories, tablet technologies, FDA regulated industry/sponsor companies, and vendor liaison functions. Representative examples of Wendy’s clinical trials billing experience include:

•Completed training in clinical trial billing regulations, cost analysis, and billing compliance for clinical trials. Recognized as respected authority on protocol cost analysis and billing compliance.

•Reviewed 100 clinical trial protocols and related documents to make coverage determinations. Negotiated clinical trial budgets to include sponsor payment for non-billable items and services.

•Made recommendation for partial breast irradiation to Medicare intermediary resulting in published recommendation verbatim as a local coverage determination.

•Translated functional requirements for database build to manage clinical trial billing and government grant finance compliance. •Managed hospital system-wide project review for research services billable to third-party payers and budget negotiations for services deemed not billable.

•Oversaw design, development, implementation, evaluation, and maintenance of policy and process flow to ensure system-wide research billing compliance. Wendy also:

•Advised biotech companies in protocol/CRF/Manual of Operations development, CRO collaborations for biostatistics and data management, site/vendor qualification, regulatory tracking, budgets and contracts, SIV, IATA training, specimen acquisition, integrity, processing, packaging, shipping, logistics, chain of custody and redistribution, monitoring, on-site SDV, EDC query resolution, AE tracking and reporting, regulatory auditing, device accountability and site performance tracking/dashboard reporting.

•Acted as field liaison with potential customers in a business development role for eSource software customizations on commercially available hardware for clinical trial data collection. Reviewed clinical trial protocols to translate data requirements into CRFs to be implemented as eSource including edit checks and boundaries, warnings and alerts.

•Directed clinical and operational aspects of sponsored/investigator-initiated clinical research studies. Managed research staff and daily clinical operations. Acted as elevation point for strategy and business decisions as well as research compliance. Administered standardized processes for financial management, strategic planning, and business development.

Upcoming Trainings

No Similar Training(s) Found

Recorded Trainings

Often investigators believe that creating a “registry” is not associated with conducting clinical trials. While this may be true to some extent, more often the creation and use of patient registries is intended to answer a research question that inv ...

A protocol deviation occurs when there is an inconsistency in a research study between the protocol that has been reviewed and approved by the FDA/Institutional Review Board (IRB) and the actual activities ...