Clinical Research Coordinator II

2 weeks ago

Stanford, California, United States Stanford University Full time
Job Title: Clinical Research Coordinator II

Stanford University is seeking a highly skilled Clinical Research Coordinator II to join our team in the Division of Gastroenterology and Hepatology. As a key member of our research team, you will be responsible for coordinating and managing clinical research studies, ensuring compliance with regulatory requirements, and providing exceptional support to our investigators and research staff.

Key Responsibilities:
  • Recruit and enroll participants in clinical trials, ensuring timely and efficient study start-up and close-out.
  • Manage and maintain accurate and up-to-date study records, including participant data, study protocols, and regulatory documents.
  • Collaborate with investigators, research staff, and sponsors to ensure seamless study execution and compliance with regulatory requirements.
  • Develop and implement effective strategies for promoting and retaining research participants, ensuring high-quality data and successful study outcomes.
  • Provide training and support to new staff and students, ensuring they are equipped to perform their roles effectively.
  • Audit and monitor study operations to ensure compliance with regulatory requirements, identifying and implementing corrective actions as needed.
  • Collaborate with principal investigators and study sponsors to monitor and report serious adverse events, resolving study queries and ensuring timely resolution.
  • Develop and manage study budgets, tracking patient and study-specific milestones, and invoicing sponsors according to study contracts.
  • Ensure regulatory compliance, regularly inspecting study documents to ensure ongoing regulatory 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 organizational skills, proficiency in Microsoft Office and database applications, and experience with research protocols and regulatory or governing bodies.
  • Knowledge of medical terminology, HIPAA, and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Working Conditions:

This position may 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.

Stanford University is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

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