The Office of Human Research Protections at West Virginia University is seeking applications for a (Remote) Quality Assurance/Quality Improvement and Education Administrator.

About the Opportunity:

As the (Remote) Quality Assurance/Quality Improvement and Education Administrator, you will lead and maintain quality improvement/assurance efforts, in addition to providing assistance for training and education and process improvement functions, in the Office of Human Research Protections at WVU. You will also Serve as senior administrator for process improvement initiatives and project manager for campus-wide initiatives in support of WVU’s Human Research Protections Program.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year
• 18 sick days per year
  (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

What you'll do:

• Maintain and analyze IRB operations metrics and reports for the WVU OHRP in support of process improvement initiatives.
• Under the direction of the Assistant Director and Director, develop, implement, and assist with outreach efforts with the WVU research community based on needs in areas of human research protections and IRB operations (e.g., presentations, webinars, technical trainings, human research compliance training sessions, etc.)
• Under the direction of the Assistant Director and Director, assist with training and education, regulator guidance, etc. with WVU departments and/or divisions.
• Under the direction of the Assistant Director and Director, serve as project manager for internal and external QA and process improvement initiatives, including but not limited to: policy and SOP development, business workflow analysis, development of HRPP tools for research community.
• Lead enterprise-wide eConsent education and implementation efforts by collaborating with other research units to streamline the eConsent process with various education and consultation methods.
• Audit and assist in maintenance and policy development of eConsent platforms to ensure electronic consent documents remain in compliance with federal, state, and local regulations and institutional policies and procedures.
• Serve as regulatory advisor/liaison for IRB, specifically for FDA-regulated studies.
• Exercise independent judgement in analysis and proactively identify areas and strategies for improvement.
• Maintain an advanced working knowledge of federal, state, and local regulations and institutional policies and procedures to ensure WVU IRBs and the HRPP are in compliance with applicable mandates.
• Under the direction of the Assistant Director, support institutional accreditation and IRB member onboarding efforts.
• Interface with internal team members as needed to resolve issues.
• Participate in regional and national conferences and educational events as needed.
• Perform other related duties as directed.

• Bachelor’s degree required.
• A minimum of five (5) years of direct experience in research quality assurance and process improvement, including past performance with business analysis, developing and analyzing business operations metrics in a human research office or research administration office supporting human research activities.
• Knowledge of federal, state, and local laws and regulations governing human subject research.
• Exceptional oral and written communication skills.
• Excellent organizational skills with ability to prioritize work and adhere to office timelines.
• Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specific criteria
• Good analytical skills and attention to detail.
• Ability to problem solve and successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization.
• Ability to proficiently use electronic tools and resources for remote work.
• Demonstrated proficiency in the MS-Office Suite.
• Demonstrated ability to work independently, exercise sound judgment and multi-task.

Preferred Qualifications:

• Master's degree preferred OR an equivalent combination of education and directly related experience.
• Experience in developing/leading research quality assurance and process improvement efforts preferred.
• High level of working knowledge of FDA regulations, including IND/IDE, emergency use, and expanded access regulations preferred.
• Experience working with multiple electronic IRB submission systems and system transition/change management preferred.

Certifications:

• Certified IRB Professional is preferred.

At West Virginia University, we leverage our talents and resources to create a better future for our state and the world. As West Virginia's land-grant university, WVU has three campuses that touch each corner of the state. The WVU System includes 518 buildings on 15,880 acres, Extension Service offices in all 55 counties, ten experimental farms and four forests.

From the groundbreaking R1 research of our flagship campus in Morgantown to the career-oriented programs of WVU Potomac State in Keyser to the technology-intensive programs at WVU Tech in Beckley — the contributions of WVU employees directly impact the 1.8 million people of West Virginia every day, no matter their role or position.

Service, curiosity, respect, accountability, and appreciation are the core values that unite Mountaineers, inspiring one another to work tirelessly and support others as they seek to reach new heights. After all, when you're a Mountaineer, impossible is just another mountain to climb.

Creating an inclusive, engaged, and dynamic learning environment is core to WVU’s academic mission. We welcome candidates who can contribute a range of ideas, approaches and experiences.

To learn more about West Virginia University, visit go.wvu.edu. View current career opportunities at careers.wvu.edu.

West Virginia University is proud to be an Equal Opportunity employer and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.