APPLICATION INSTRUCTIONS:

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• CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.

• If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants.

JOB DESCRIPTION AND POSITION REQUIREMENTS:

Penn State’s Office for Research Protections (ORP) seeks a highly motivated and experienced professional to serve as a Quality Assurance and Data Management Specialist who will play a crucial role in ensuring researcher adherence to IRB-approved protocols and research data management plans.

About ORP: The ORP, part of the Office of the Senior Vice President for Research, plays a pivotal role in supporting Penn State’s vibrant research community, boasting an annual research expenditure of $1.23 billion and ranking among the top 30 public research universities in the nation. The ORP oversees the research compliance and administrative processes across the University. In this dynamic position, the successful candidate will monitor and audit IRB protocol compliance, assist with the management of ClinicalTrials.gov accounts, support FDA-regulated studies, and uphold research data management standards across the University to contribute to a community of research excellence.

Why Join us? At Penn State, we are dedicated to supporting groundbreaking research with the highest standards of compliance. As a Quality Assurance Specialist, you'll be a vital part of our team, ensuring research integrity and regulatory adherence. Enjoy a stimulating work environment and contribute to our mission of advancing knowledge and innovation.

The Quality Assurance Specialist will report to the Executive Director of Ethical Research and Outreach.

Responsibilities: As part of the Ethical Research and Outreach team, the Quality Assurance specialist will have the following responsibilities:

• Research Data Management Compliance: Develop tracking systems and an audit process for research data management and sharing plans. Conduct audits to evaluate compliance with research data management and sharing plans. Address non-compliance issues, create resources for research compliance, and work with stakeholders to improve data management practices. ClinicalTrials.gov Management: Assist with management of the University's ClinicalTrials.gov account, ensuring compliance with FDAAA, ICMJE, CMS, and NIH regulations. Provide guidance on registration and reporting requirements and support researchers with compliance issues.
• IRB Monitoring and Auditing: Conduct routine and directed audits of IRB-approved studies. Monitor compliance with institutional, federal, and