The Office of Research Integrity and Compliance is seeking applications for an IRB Continuous Improvement Manager. Reporting to the Director of the Human Research Protection Program (HRPP) at West Virginia University Institutional Review Board (WVU IRB), the IRB Continuous Improvement (CI) Manager will develop and review process and communication flow structures to ensure they continuously support the dynamic, rapidly growing research community at WVU. Work ranges from leading multifaceted process/continuous improvement to conducting specific quick-win events. This position will focus heavily on IRB communications, operational processes, and collaborations between departments and external agencies.
In order to be successful in this position, the ideal candidate will:
Develop, implement and lead improvement initiatives surrounding research study submissions and reviews; IRB office operations; SOP development and delivery; IRB committee meeting packet delivery; IRB committee meeting activities and documentation; IRB committee member recruitment and training; researcher, investigator and staff training development and delivery; interdepartmental process communication and other processes, as needed.
Develop metrics to identify areas for improvement in the initiation and conduct of research as it specifically relates to IRB operations and research compliance.
Improve the efficiency, consistency, transparency, communication, and, timely initiation of research protocols, while implementing continuous improvement initiatives designed to ensure ongoing optimal performance.
Evaluate and provide recommendations on process improvement to increase efficiency and effectiveness of regulatory compliance, improve internal and external customer relations, and sustain improved performance through continuous improvement initiatives.
Facilitate ongoing collaboration between researchers, IT, constituents conducting internal processing of research, and external clients to create an infrastructure that supports research growth and diversity.
Develop, recommend, and continuously improve policies, procedures, and strategies to streamline workflow of research compliance operational processes and ensure stakeholder objectives.
Create processes and/or facilitate process changes by integrating new systems/processes with existing systems throughout research compliance administration.
Ensure that all developments and improvement processes are compliant with local, state and federal regulations and laws governing research operations as well as Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation standards.
Maintain and measure project performance by maintaining timelines and by using tracking/analysis tools.
Analyze complex data, draw meaningful conclusions, and report conclusions in a clear, understandable format to all stakeholders at all levels.
Master’s degree required. Bachelor's and related experience will be considered in lieu of Master's degree.
3 or more years’ experience working with people, projects, programs and processes to include:
Research background in either processes and implementation, an integrated health system, academic institution of higher education, IRB operations or regulatory compliance, or other related area.
Experience implementing/managing multiple projects with significant scope that cut across multiple departments or functions.
IT experience with working knowledge of data analytics, spreadsheets, websites and systems specific to both research, research compliance, quality improvement and process /continuous improvement.
Experience to have gained the ability to differentiate between research, quality improvement programs and evidence-based practice/evidence-based medicine initiatives, highly desirable.
Experience with document control and standardization for quality management systems (QMS) such as ISO 9000/9001, highly desirable.
One or more certifications including Lean Six Sigma Green/Black Belt, Project Management Professional (PMP) certification, Certified IRB Professional (CIP), Certified IRB Manager (CIM), Certified in Healthcare Research Compliance (CHRC) highly preferred.
Internal Number: 09620
About West Virginia University
At West Virginia University, we pride ourselves on a tireless endeavor for achievement. We are home to some of the most passionate, innovative minds in the country who push their limits for the sake of progress, constantly moving the world forward. Our students, faculty, and staff make this institution one of the best out there, and we are proud to stand as one voice, one university, one WVU. Find out more about your opportunities as a Mountaineer at http://hr.wvu.edu/.
West Virginia University is an Equal Opportunity/Affirmative Action Employer and 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 individuals, including minorities, females, individuals with disabilities and Veterans.