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Gabrielle Hempel

Gabrielle Hempel

Regulatory Compliance/IT Client Support Coordinator

Schulman IRB

I am a Regulatory Compliance/IT Client Support Coordinator for Schulman IRB. Prior, I attended the University of Cincinnati, where I studied Neuroscience/Psychology and Criminal Justice. I'm truly passionate about my work and eager to educate myself more about IT infrastructure/development. I have pursued various courses...

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Schulman IRB

Regulatory Compliance/IT Client Support Coordinator

-Maintain validated state of Schulman's regulated systems and support implementation of new systems to the environment; utilize governing regulations, perform risk assessments, and produce validation deliverables to ensure compliance.
-Ensure records and procedures are in compliance with current GxP requirements.
-Coordinate testing efforts of IT and business teams with regards to requirements, resource planning, test coverage, and test strategies; provide test execution training and assist team with discrepancy management.
-Identify any potential quality issues per defined process, conduct root cause analysis and escalate potential quality issues immediately.
-Support and liaise with auditors or regulatory agencies regarding system's validated state as well as facilitate collaboration with external partners.
-Own and revise the Disaster Recovery and Business Continuity plans as needed.
-Respond and provide support to Schulman clients using LiveChat, telephone calls, and emails.
-Manage, document, track, and resolve client support requests to ensure timely resolution and elevate to a higher level if necessary.
-Manage registration requests and updates to client access systems.
-Manage technical hardware and software issues in coordination with IT.
-Build, maintain, and improve Prologue database for clients who need ready access to an information-rich, dynamic search engine.
-Define standards and measures needed for enhancements to meet needs of Prologue subscribers.
-Protect confidentiality, integrity, and availability of company data.
-Add and deepen content including state/provincial laws and international law.