Clinical Research Coordinator Associate

The Pediatric Vascular Laboratory led by Dr. Tierney at Stanford University is seeking two Clinical Research Coordinator Associates (2 Two Positions) to perform duties related to the coordination of clinical studies.  Coordinate moderately complex aspects of one or more clinical studies.  Work under close direction of the principal investigator and/or study coordinator/supervisor.

Duties include:

• 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. Assist with onboarding of a new team member.
• 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.

* - Other duties may also be assigned