Clinical Research Coordinator Associate (1-Year Fixed-Term)

The Department of Medicine (DoM), Clinical Research Hub (CRH) at Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies in the disciplines of Infectious Disease and other therapeutic areas. This onsite role involves direct patient contact in both inpatient and outpatient settings, working on a variety of interventional and observational clinical research trials and studies.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies.
• Coordinate studies from start-up through close-out, including determining eligibility, gathering consent, and 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 study-related documents, and complete case report forms.
• Ensure compliance with research protocols; 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, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors as the primary contact.
• Monitor expenditures and adherence to study budgets; resolve billing issues in collaboration with finance and/or management staff.
• Interact regularly with the principal investigator to ensure patient safety and proper study conduct.
• Ensure essential documentation and recording of patient and research data per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.

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 related education and relevant experience.
• Must possess and maintain a valid California non-commercial Class C Driver's License.
• Ability to drive day or night; must comply with the California Vehicle Code and Stanford University driving requirements when conducting university business.

Skills

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Certifications

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.