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Regulatory Specialist

Spring, TX

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Under supervision, coordinates the regulatory and Institutional Review Board (IRB) activities of clinical research being conducted within the US Oncology Research Network. Collaborates with internal research teams and external pharmaceutical (sponsor) clients to ensure compliance with federal regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.

Receives, reviews and analyzes Serious Adverse Event reporting requirements received from sponsor ensuring that the information matches content in the research protocol and compiles the Safety Clinical Trial Information form which guides site staff in appropriate reporting requirement.

Receives Serious Adverse Event reports from sites in a variety of sponsor mandated formats and critically reviews the report to be able to provide accurate and timely reporting of Serious Adverse Events to the IRB for review. 

Ensures accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. Analyzes regulatory requirements, identify potential conflicts, and have thorough knowledge and ability to apply federal regulations and USOR policies. Maintains awareness, excellent comprehension and appropriate application of relevant regulations.

Schedule 8:00am-4:30pm M-F

Pay Rate: $25 - $26.50

**This is a 3 month contract to hire position.**

Job Requirements

Bachelor’s degree in related field required**
• 2 years of Clinical research knowledge is required, 1 year regulatory specialist experience required, 1 year oncology experience preferred.*
• Proficiency with computer systems and Microsoft Office (Outlook, Word, PowerPoint, and Excel) required. 
• Discretionary decision-making and independent judgment skills. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Must be precise, thorough, reliable, and perform daily activities with minimal supervision. 
• Knowledge of clinical research process and regulations. Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations. 

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