Clinical Research Coordinator – Surgical Planning

Stanford University is seeking a Clinical Research Coordinator 2 as part of the new Surgical Planning Clinical service, 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. Perform advanced technical research utilizing and/or developing complex experimental equipment, devices, specimens, plans, designs, reports, and/or data analysis.

Contributes to or may have responsibility for the planning, design and implementation of complex multiple disciplinary projects and the overall clinical service. Provides supervision and instruction to technicians, and/or support staff.

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.
• Support complex scientific and research programs; analyze data, monitor and oversee experimental process, and design and develop prototypes, specialized equipment, and/or systems.
• Collaborate with scientists, engineers, surgeons, clinicians or senior administrative officers to oversee complex non-routine analyses, select optimum solutions, design and develop special purpose equipment and/or systems, and perform corrective modifications to equipment and system designs.
• Contribute to or may have lead responsibility for the planning, design, and implementation of scientific, clinical or engineering initiatives, and work toward project objective.
• Oversee and make decisions independently for operation, maintenance, and development of laboratory space and clinical program.
• Oversee and prepare periodic financial and technical reports and operating plans. Lead all negotiations with billing and insurance with regards to program activities reimbursement.
• Establish, communicate, and enforce compliance with health and safety policies and procedures.
• Oversee development of training manuals and safety guidelines, and train new instrumentation users, researchers, and/or technical staff.

Desired Qualifications

Disclaimer: A strong candidate does not need to possess ALL of the following qualifications, but should have at least some of these skills:

• Significant prior research and management experience, preferably in an engineering or cardiovascular-related field. The ability to think critically and carry out experiments independently is required.
• Strong engineering fundamentals in fluid and solid / continuum mechanics, numerical methods, and/ or computational science, preferably with a PhD in engineering or related field.
• Solid software engineering skills including as programming in Python and / or Matlab.
• Experience with CAD software and/or 3D modeling software.
• Familiarity with image analysis (3D Slicer, Mimics) or medical imaging (optional).
• Experience running engineering simulations and performing associated analysis of simulation results. This includes finite element methods or computational fluid dynamics (Simvascular). Confidence with troubleshooting simulation results to ensure high quality outputs is needed.
• If coming from an…