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Clinical Research Coordinator Associate

4 weeks ago

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

Stanford Radiology is committed to delivering exceptional patient care by harnessing technology, innovation, and compassion. We aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in-vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity.

Job Responsibilities
  • Coordinate various aspects of clinical studies, including recruiting participants, preparing study procedures, submitting regulatory maintenance, and collecting data.
  • Work under the close direction of the principal investigator and/or study coordinator/supervisor.
  • Coordinate moderately complex tasks related to the studies.
  • Serve as primary contact with research participants, sponsors, and regulatory agencies.
  • Determine eligibility of and gather consent from study participants according to protocol.
  • Assist in developing recruitment strategies.
  • 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 other study-related documents, and complete study documents/case report forms.
  • Ensure compliance with research protocols, and review and audit 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, acting as primary contact.
  • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
  • Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
  • Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
  • Participate in monitor visits and regulatory audits.
Requirements
  • Bachelor's degree in a related field or an equivalent combination of related education and relevant 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 is preferred.
Work Environment

This is a hybrid role. Occasional evening and weekend hours.

Work Standards
  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.