Clinical Research Coordinator — Trials & Compliance Lead

Stanfordlivetickets; Palo Alto (CA); Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Stanford University is seeking a Clinical Research Coordinator Associate to oversee the management and implementation of multiple research protocols at Stanford Hospital and Clinics. You will ensure regulatory compliance, assist with IRB submissions, consent processes, data collection, and CRF preparation, working with Principal Investigators.

Responsibilities include recruitment, subject scheduling and follow-up, adverse event reporting, drug accountability, and maintaining study supplies,

Qualifikationen

• Preparation of initial study documents for IRB submission in compliance with local, state and federal regulations.
• Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines.
• Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations.

Aufgaben

• Advise the IRB of amendment changes to the protocol and complete annual protocol renewals.
• Recruit, screen, assist in the informed consent process and enroll subjects.
• Collect, record and maintain data files and Case Report Forms for the various studies.
• Schedule diagnostic and research evaluation visits and perform study-related assessments including collection of blood samples, processing and shipment.
• Maintain drug accountability, adequate study supplies and equipment.
• Oversee subject compliance to the study protocol and report adverse events to physicians for documentation.
• Report all serious adverse events promptly to investigators, sponsors and the IRB.
• Protect the rights, safety and well-being of human subjects involved in the clinical trials.

Kenntnisse

Interpersonal Skills

Jobbeschreibung

Stanford University is seeking a Clinical Research Coordinator Associate to oversee the management and implementation of multiple research protocols at Stanford Hospital and Clinics. You will ensure regulatory compliance, assist with IRB submissions, consent processes, data collection, and CRF preparation, working with Principal Investigators.

Responsibilities include recruitment, subject scheduling and follow-up, adverse event reporting, drug accountability, and maintaining study supplies,