Clinical Research Coordinator II

14 hours ago

Stanford CA, United States Stanford University Full time
Job Summary

We are seeking a highly skilled Clinical Research Coordinator II to join our team at Stanford University. The successful candidate will provide support for clinical research efforts in the Division of Gastroenterology and Hepatology, with a focus on testing novel therapies in chronic liver disease.

Key Responsibilities
  • Independently conduct 4-6 new gastroenterology complex clinical drug studies to test novel therapies in chronic liver disease, including the MERCK IBD Study.
  • Determine effective strategies for promoting and recruiting research participants and retaining participants in long-term clinical trials.
  • Oversee data management for research projects, including developing and managing systems to organize, collect, report, and monitor data collection.
  • Extract, analyze, and interpret data to inform research decisions.
  • Develop project schedules, targets, measurements, and accountabilities, as assigned.
  • Formally supervise, train, and/or mentor new staff or students, as assigned, including preparing or assisting with the preparation of performance evaluations.
  • Audit operations, including laboratory procedures, to ensure compliance with applicable regulations.
  • Provide leadership in determining, recommending, and implementing improvements to policies and processes.
  • 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 and regularly inspect study documents to ensure ongoing regulatory compliance.
  • Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
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.
  • Proficiency in Microsoft Office and database applications.
  • Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations.
  • Knowledge of medical terminology.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Working Conditions

The position may require occasional sitting, reaching above shoulders, performing desk-based computer tasks, using a telephone, and writing by hand. Rarely, the employee may be required to kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, lift, carry, push, and pull objects that weigh 40 pounds or more. The position may also require working with or being in areas where 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. Uses and promotes safe behaviors based on training and lessons learned.

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