Position Summary: The primary purpose of this position is to advance the mission and services of the Department of Pediatrics Clinical Research Services program to support effective clinical research in children’s health. Key priorities include driving strategic initiatives, overseeing and improving program operations, and ensuring compliance with federal regulations and University policies.
Major Duties / Job Description
Key Initiatives & Strategic Planning (50%)
• Strategic planning and operational implementation of a clinical research center for children, including:
collaborating with University and health system research leadership to ensure research needs are met
developing the infrastructure for a pediatric clinical research unit
partnering with key stakeholders to define service model
• Provide leadership for pediatric clinical research nurses, including:
developing new and improved pathways for ensuring clinical competencies,
defining processes for effective management of research participants in the health care system, and
• Partner with internal and external offices and committees to facilitate change and to make recommendations for improving clinical research compliance and processes.
Research Operations (50%)
• Provide strategic direction and oversight for clinical research operations; responsible for all aspects of clinical trial operations including monitoring, fiscal oversight, data integrity, patient safety, and regulatory compliance. • Oversee all aspects of clinical research personnel management, staffing decisions and training; directly supervise lead program roles including the Data Manager, Regulatory Manager, Lead Research Nurse, and Research Project Managers • Effective financial management of the program, including partnering with CTSI CTFS for successful management of industry-sponsored trials, appropriating use of philanthropic funds, and determining rates for services, and development of the annual budget. • Further develop program operations to effectively accommodate research growth while developing revenue-neutral infrastructure. • Oversee compliant facility operations, including a research specimen processing lab and monitored specimen storage. • Development of policies and procedures to promote adherence to good clinical practices, regulations, and University policies. • Direct and prioritize program resources and staff effort • Serve as a resource for 100+ clinical investigators and 50+ clinical research staff members
Required Qualifications: • BA/BS with at least 12 years of experience, or advanced degree with 10 years of experience; years of experience must include substantial management experience with a demonstrated history of excellence in group leadership/supervision, as well as technical and operational mastery in conducting clinical research studies in children and managing pediatric clinical research programs. • Research certification (such as CCRC from ACRP or CCRP from SoCRA) • Expert knowledge of federal regulations, ICH Good Clinical Practices, and ethical principles of human subjects research. • Significant experience leading clinical research teams and supporting the professional development of clinical research staff • Expert understanding of pre-award and post-award financial management of clinical trials, including budget development, coverage analysis, and research billing. • Experience supporting a variety of research sponsors, including federal grants and subawards, pediatric research networks and foundations, and industry contracts. • Experience using a clinical trials management system for project and program management • Experience collaborating with key partners across an academic health system and University research community.
Preferred Qualifications: • Registered Nurse with research nursing experience, including managing pediatric patient participation in investigational drug and/or device trials. • Master’s degree in health or research related field • Experience implementing new technology solutions, research workflows, and administrative procedures with clinical research teams • Experience with OnCore CTMS, Florence eBinders, Epic EHR, REDCap
Internal Number: 340340
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.