The Childhood Research Obesity Prevention Lab under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) within Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.

The selected candidate must have the ability to implement, organize and perform oversights of all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). S/he will lead the team of clinical researchers and clinical research coordinators in conducting the research studies in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research management experience is required. Previous clinical trial experience at Stanford and/or LPCH is highly desirable.

The Pediatric GI Division has approximately 40 pediatric gastroenterologists with nationally recognized expertise through their research, teaching, and clinical programs which attracts leading candidates to their fellowship program. We have a mission of healing children with digestive disease through innovation. Our Pediatric GI Specialty provides comprehensive GI care to children throughout our region. We lead global destination programs that deliver highly specialized care and train the next generation of pediatric gastroenterologists, and inspire hope through innovation. Our high quality, collaborative care is driven by cutting-edge research and active partnerships between doctors, nurses, and staff throughout the Stanford Medicine Children’s Health network, scientists at Stanford University, and patient families. Together, we are changing the lives of children today and shaping care for tomorrow.

The Department of Pediatrics is a dynamic, stimulating place to work and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

Duties include:

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.

• Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.

• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.

• Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.

• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.

• Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.

• Lead or chair committees or task forces to address and resolve significant issues.

• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.

• Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.

• Assist with analysis of data and preparation of manuscripts and scientific presentations.

• Other duties may also be assigned

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $107,000.00 to $136,000.00.