Provides leadership for designated areas of the Human Research Protection Office (HRPO) and Institutional Review Board (IRB) and works collaboratively with the Executive Director to assure compliance with federal regulations, state laws, accreditation requirements and institutional policies. Key responsibilities include data analytics, education, management of designated staff, and ongoing review and revision of policies and procedures.
PRIMARY DUTIES AND RESPONSIBILITIES:
Responsible for revising and developing policies, procedures and guidances related to human subjects protections.
Develop and oversee HRPO data analytics with regard to workflow processes, education and support activities (e.g. HRPO SWAT! and HRPO Study Initiation Program), and IRB operations including member evaluations and membership efforts. Identify and assess key data for monitoring and improving the activities of HRPO and the IRB. Design and implement surveys or other tools to provide continuous feedback from the research community.
Supervise review, education, or operational personnel. Supervise training and provide continuing education to assure compliance with applicable regulations, laws, guidelines, policies, and procedures. Interview and hire for vacant positions, maintain position descriptions, meet regularly with direct reports to provide feedback, establish goals, assess performance, and counsel as appropriate. Prepare performance evaluations, disciplinary actions; leave records and recommendations for salary increases as appropriate.
Oversee integration of processes and procedures for consistency and effectiveness between the HRPO review teams. Collaborate with HRPO leadership to maintain written policies and procedures in support of effective and efficient workflow and review activities.
Act as a resource and point of contact for staff, IRB members, and the research community with regard to study design and conduct and IRB submission and review processes.
Act as the administrative and regulatory representative at IRB meetings. Provide support and expertise to IRB Chairs in assessment of regulatory applicability and compliance with IRB policies and procedures.
Oversee and conduct HRPO and IRB internal quality assurance and quality improvement activities.
Other duties as assigned.
Master’s level degree required or bachelor’s degree with comparable research and management experience.
5 years of experience in human subject research, research administration and/or regulatory compliance.
Experience in human subjects research education and compliance.
Demonstrated experience and success in progressive levels of management required.
Strong customer service, communication and organizational skills.
Ability to multi-task with a strong attention to details and accuracy.
Flexibility and ability to adapt to a changing environment.
Efficient in Microsoft Word, Excel, and PowerPoint.
Professional demeanor and ability to work independently.
Certified IRB Professional (CIP) status required when eligible.
Direct IRB experience in a management or leadership role
Efficient in an IRB-specific software system
Experience in an AAHRPP-accredited University Human Research Protection Program compliance unit
Excellent communication and customer service skills both written and verbal
Must have the capacity to communicate effectively with a variety of customers including faculty, research coordinators, institutional officials, and departmental staff
Demonstrated management and supervision, leadership, and administrative capabilities
Medical knowledge and experience with the conduct of clinical research
Analytic skills and ability to problem solve within the framework of major federal regulatory requirements, state laws, accreditation standards, and institutional policies and procedures
Experience with federal regulations and standards including Human Subject Protections, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report
Strong independent decision making
Conceptual thinking and problem solving as well as the ability to apply knowledge to a variety of situations
Ability to manage several projects at once
Demonstrated organizational skills
Cooperative and positive attitude to contribute to the team
Internal Number: 41940
About Washington University in St. Louis
Founded in 1853, Washington University in St. Louis is nationally and internationally renowned for teaching, learning, research, service to society, and patient care with highly ranked schools spanning arts and sciences, architecture and fine arts, business, engineering, law, social work, and medicine. Today the university has more than 15,000 undergraduate and graduate students, 3,800 faculty, and 15,400 total employees. The university’s annual operating budget is over $3.0 billion and has an endowment of $7.2 billion.
Positioned to meet imperatives confronting the nation and the world, Washington University takes its responsibility seriously. Through innovative research, the university is committed to creating the new knowledge necessary to achieve a bright and sustainable future. During the 2017 fiscal year, grants and contracts totaling more than $643 million supported faculty research efforts across all schools of the university with more than 3,000 research projects underway each year. The Washington University School of Medicine is one of the largest recipients of funding for research and training from the National Institutes of Health, with the majority of the funds awarded for research in cancer, diabetes, cardiovascular disease, infectious disease and genomics.