Cancer Clinical Research Project Manager – Start-Up and Educator (Remote)

Stanford University is seeking a Cancer Clinical Research Project Manager to support the mission of the Stanford Cancer Institute in reducing cancer mortality through comprehensive research and education programs. The role involves overseeing clinical trials, managing data, and ensuring regulatory compliance while collaborating with multidisciplinary teams.

Responsibilities:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work
• 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
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract
• Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed

Requirements:

• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience
• Strong interpersonal skills
• Proficiency with Microsoft Office and database applications
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
• Knowledge of medical terminology
• Knowledge of clinical trials data management and clinical quality management
• Clinical knowledge in the field of Hematology
• Knowledge of various projects and implementation strategies
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification