Clinical Research Coordinator 2

3 days ago

Stanford, California, United States Stanford University Full time
Job Summary

The Division of Gastroenterology and Hepatology at Stanford University is seeking a highly skilled Clinical Research Coordinator II to support clinical research efforts in the division. The successful candidate will be responsible for independently conducting 4-6 new gastroenterology complex clinical drug studies to test novel therapies in chronic liver disease.

Key Responsibilities
  • Oversee subject recruitment and study enrollment goals, developing effective strategies for promoting and recruiting research participants.
  • Manage data collection, organization, and analysis, ensuring compliance with FDA regulations and Institutional Review Board requirements.
  • Develop project schedules, targets, and measurements, leading team meetings and preparing minutes.
  • Supervise, train, and mentor new staff or students, including hiring, performance evaluations, and instruction on project work.
  • Audit operations to ensure compliance with regulations, identifying and implementing corrective actions.
  • Collaborate with principal investigators and study sponsors, monitoring and reporting serious adverse events, and resolving study queries.
  • Provide leadership in determining and implementing improvements to policies and processes, defining best practices.
  • Develop study budgets, tracking patient and study milestones, and invoicing sponsors according to study contract.
  • Ensure regulatory compliance, regularly inspecting study documents to ensure ongoing compliance.
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 in Microsoft Office and database applications, and experience with research protocols and regulatory bodies.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Working Conditions

The position may require working with hazardous materials and/or exposure to chemicals, blood, body fluid, or tissues, and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs.

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