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Clinical Research Coordinator

2 months ago

Stanford CA, United States Stanford University Full time
Job Summary

The Clinical Research Coordinator/Specialist is responsible for the overall management and implementation of assigned research protocols, ensuring efficiency and regulatory compliance.

Key Responsibilities
  • Prepare and submit initial study documents to the Institutional Review Board (IRB) in compliance with local, state, and federal regulations.
  • Collect, record, and maintain complete data files using good clinical practice and adhering to HIPAA regulations.
  • Participate in data retrieval, reporting, and preparation of files and Case Report Forms for various studies.
  • Interact with research participants, scheduling diagnostic and research evaluation visits, and performing study-related assessments.
  • Maintain drug accountability, study supplies, and equipment.
  • Oversee subject compliance to study protocols, report adverse events, and protect the rights and safety of human subjects.
  • Coordinate collection of study specimens and processing, collect and manage patient and laboratory data, and manage research project databases.
  • Ensure compliance with research protocols, review and audit Case Report Forms, and prepare regulatory submissions.
  • Assemble study kits, monitor scheduling, and coordinate documents for study visits.
Requirements
  • Two-year college degree and two years of related work experience or a Bachelor's degree in a related field or an equivalent combination of education and experience.
  • Proficiency in Microsoft Office and knowledge of medical terminology.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Working Conditions

The Clinical Research Coordinator/Specialist will work in a fast-paced environment, occasionally sitting, reaching above shoulders, and performing desk-based computer tasks. The position requires occasional evening and weekend hours.

Stanford University is an equal opportunity employer and welcomes applications from diverse candidates. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities.