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Clinical Research Coordinator Associate

2 months ago

Stanford, California, United States Stanford University Full time

Job Summary:

Stanford University is seeking a highly skilled Clinical Research Coordinator Associate to join our team in the Division of Sleep Medicine in the Department of Psychiatry & Behavioral Sciences. The successful candidate will be responsible for performing duties related to the collection of clinical data and the coordination of clinical studies.

Key Responsibilities:

  • Serve as primary contact with research participants, sponsors, and regulatory agencies.
  • Coordinate studies from startup through close-out.
  • 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
  • Valid State of California Certified Phlebotomy Technician I (CPT I) Certificate
  • 1 year of phlebotomy experience
  • 2 years of related experience in clinical trial coordination

Preferred Qualifications:

  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification

Working Conditions:

  • Occasional evening and weekend hours
  • This position is based in Stanford's Research Park and Stanford main campus and has the option of telecommuting/hybrid schedule subject to operational needs