Quality Assurance and Data Management Specialist

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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 state regulations, track audit outcomes, and handle self-assessment audits to ensure IRB protocol adherence.
• FDA QA Support:Offer support for FDA-regulated protocols, including conducting Ancillary Reviews and assisting with FDA documentation. Serve as a regulatory expert and monitor IRB compliance with FDA regulations.
• QA-related Activities and Special Projects:Engage in special projects related to quality assurance, policy development, and research misconduct investigations as needed.
• Assessment: Contribute to annual reports and identify areas of improvement to advance program goals.
• Collaborate: Work closely with University stakeholders, including researchers and other program areas and units such as the Human Research Protection Program, Office of Sponsored Programs, and University Libraries.

Work Arrangement: The position can be performed remotely within the US and may require occasional on-site training delivery at Penn State's commonwealth locations, particularly University Park, and may hire, train, supervise, and/or evaluate assigned staff. Standard work times will be in EST.

Education and Experience: This position will be filled at the Advanced Professional level and at the minimum, requires a Bachelor's Degree or higher and 3+ years of relevant experience, or an equivalent combination of education and experience.Following are the additional qualifications:

• Demonstrated effectiveness in the management and coordination of complex programs and tracking materials.
• Proven experience in quality assurance, research compliance, managing research data management plans, or related areas.
• Knowledge of clinical trials regulations and research data management practices.
• Exceptional verbal and written communication skills to summarize and convey research compliance information to a diverse audience.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving abilities.
• Exceptional professionalism with a strong customer-service orientation required.
• Proficiency with Microsoft Office expected.

Application: Please include a cover letter in your application materials in addition to a resume for full consideration.

Penn State and the ORP are committed to advancing diversity, equity, and inclusion, and we encourage applications from individuals in historically underrepresented and underserved groups.

Penn State offers competitive benefits to full-time employees, including medical, dental, vision, and retirement plans, in addition to tuition discounts (75% discount for spouse and children), and paid holidays. Please visit https://hr.psu.edu/current-employee/benefits for more detailed information.

The salary range for this position, including all possible grades is:

Salary Structure - additional information on Penn State's job and salary structure.

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