Stanford University School of Medicine is seeking a QA/QC program manager to facilitate consistency, efficiency and enhance the submission of successful CTSA-related information packages to NCATS and NIH grants management. Reporting to the CTSA Principal Investigator with a dotted line to the CTSA Executive Director, this position will collaborate on improvement initiatives within Spectrum to enhance the quality of our submissions including the annual progress report to NCATS and the eRA Human Subjects System and streamline communications within Spectrum and between Spectrum, NCATS and the NIH. The ideal candidate will possess excellent interpersonal and professional skills to work with a broad range of investigators and their teams across the School of Medicine engaged in adult and pediatric clinical and translational research. This individual will help develop and implement processes to improve the quality of CTSA-related document submissions to NCATS, the eRA Human Subjects System and NIH grants management, promote proactive and timely communications, and enhance engagement and coordination with departments and their CTSA faculty and staff to review and obtain institutional approvals for submitted documents. This includes performing quality reviews and management of all CTSA-related submissions to NCATS. The QA/QC program manager will compile data on the most common errors that occur during submission of documents to NCATS and develop a plan for addressing these errors in future submissions. Information on common errors will also be incorporated into our training workshop curriculum.

Duties include:

• Promote proactive and timely communications, and enhance engagement and coordination with departments and their CTSA faculty and staff to review and obtain institutional approvals for submitted documents.
• Use a data-driven approach to evaluate the effectiveness of new processes and use the data to implement continuous and timely improvement.
• Develop metrics based on CTSA reporting requirements. Analyze and interpret policies; develop, revise and implement procedures for managing projects
• Organize and/or participate in outreach activities that may include developing communications and training, planning/promoting events.
• Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
• Represent the program or function within the department, unit or school.
• Commit resources and provide information and/or training.
• Represent the program at the university level and to external/internal stakeholders and constituencies.
• Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
• May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting. Assess training needs and may develop associated training.
• May direct and/or supervise staff.          

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Demonstrated experience with positively interacting with a broad range of collaborators
•  Master's degree preferred
• Experience in NIH program and grants management
• Excellent interpersonal skills.
• Proficiency in Microsoft Office and database applications.
• Experience with the clinical research protocol pre award process (budgets, contracts, regulatory reviews)
• Knowledge of regulations governing clinical research (FDA regulations, Institutional Review Board requirements, Good Clinical Practices, HIPAA).
• Knowledge of regulatory terminology.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
• Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
• Demonstrated creativity, problem solving, critical analysis, initiative, judgment and decision-making skills.
• Demonstrated ability to develop and meet budget goals.
• Demonstrated solid planning and organizational skills.
• Demonstrated experience working independently and as part of a team.
• Excellent interpersonal, written and oral communication skills.
• Strong relevant subject matter knowledge.
• Ability to direct the work of others, for jobs requiring supervision.
• Data management and maintenance skills in various applications

CERTIFICATIONS & LICENSES:

None

PHYSICAL REQUIREMENTS*:

• Constantly perform desk-based computer tasks.
• Frequently stand/walk, sitting, grasp lightly/fine manipulation.
• Occasionally use a telephone.
• Rarely lift/carry/push/pull objects that weigh 11-20 pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

Additional Information

• Schedule: Full-time
• Job Code: 4122
• Employee Status: Regular
• Grade: J
• Requisition ID: 88261