Clinical Research Coordinator Associate

2 days ago


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

The Clinical Research Coordinator Associate will be responsible for the overall management and implementation of assigned research protocols, ensuring efficiency and regulatory compliance. This role will work closely with the clinical trials research team and report to Principal Investigators conducting clinical research at Stanford Hospital and Clinics.

Key Responsibilities
  • Prepare initial study documents for IRB submission, adhering to local, state, and federal regulations.
  • Advise the IRB of amendment changes to the protocol and complete annual protocol renewals.
  • Recruit, screen, and assist in the informed consent process, enrolling subjects in accordance with good clinical practice guidelines.
  • Collect, record, and maintain complete data files using good clinical practice, adhering to HIPAA regulations.
  • Participate in data retrieval, reporting, and preparation of files and Case Report Forms for various studies.
  • Interact with subjects, scheduling diagnostic and research evaluation visits, performing study-related assessments, and collecting blood samples.
  • Maintain drug accountability, adequate study supplies, and equipment.
  • Oversee subject compliance to the study protocol, obtaining information regarding changes in medications or adverse events, and reporting findings to physicians.
  • Report all serious adverse events promptly to investigators, sponsors, and the IRB.
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.
  • Strong interpersonal skills.
  • Proficiency with Microsoft Office.
  • Knowledge of medical terminology.
Preferred Qualifications
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification.
Working Conditions

Occasional evening and weekend hours.



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