Clinical Research Coordinator/Specialist

2 days ago

Stanford CA, United States Stanford University Full time
Job Summary

The Clinical Research Coordinator/Specialist is responsible for the overall implementation of assigned research protocols, ensuring efficiency and regulatory compliance. This role will work closely with the clinical trials research team and report to the Clinical Research Manager and Principal Investigators.

Key Responsibilities
  • Collect, record, and maintain complete data files using good clinical practice in accordance with HIPAA regulations.
  • Participate in data retrieval, reporting, and preparation of files and Case Report Forms for various studies.
  • Schedule diagnostic and research evaluation visits, perform study-related assessments, and collect and process blood samples.
  • Maintain adequate study supplies and equipment.
  • Oversee subject compliance to the study protocol, obtain information regarding changes in medications or adverse events, and report findings to physicians.
  • Protect the rights, safety, and well-being of human subjects involved in clinical trials.
  • Coordinate collection of study specimens and processing.
  • Collect and manage patient and laboratory data for clinical research projects.
  • Manage research project databases, develop flow sheets, and complete study documents/case report forms.
  • Ensure compliance with research protocols and review case report forms for completion and accuracy with source documents.
  • Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
  • Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Requirements
  • 1+ years of Clinical Research Coordinator experience.
  • Spanish speaking preferred.
  • Two-year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
  • Proficiency with Microsoft Office.
  • Knowledge of medical terminology.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.
Working Conditions

This role requires occasional sitting, reaching above shoulders, performing desk-based computer tasks, using a telephone, and writing by hand. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, or lift, carry, push, and pull objects that weigh 40 pounds or more.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Occasional evening and weekend hours.

Uses and promotes safe behaviors based on training and lessons learned.

Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide.

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