Clinical Trials QA & Compliance Analyst

Yale University; New Haven (CT); Ibrido; USD 68.000 - 121.000; Tempo pieno

Descrizione del lavoro

Yale University is seeking a Clinical Trials Office Quality Assurance Analyst in New Haven to support quality management for cancer center clinical trials, focusing on QC, monitoring, and inspection readiness. You will coordinate internal monitoring, track deviations and CAPAs, and support timely follow-up to strengthen data integrity.

The role requires collaboration with investigators, HRPP and IRB, and requires expertise in regulatory knowledge and GCP.

Competenze

• Professionalism, maturity, good judgment and ability to handle confidential material and PHI.
• Self-directed with ability to plan, research and conduct projects with minimal supervision.
• Organized and capable of handling multiple/diverse projects simultaneously.
• Advanced interpersonal, oral and written communications with diverse stakeholders.
• Solid understanding of clinical research processes from start-up to close-out.

Mansioni

• Facilitate review of activities related to human subject research for safety, compliance and integrity.
• Analyze protocols to customize audit plans for protocol-specific benchmarks.
• Assess risk and stratify studies from QC/regulatory perspective.
• Evaluate trial conduct for compliance with policies, regulations and GCP.
• Review medical records and communicate findings to investigators; assess level of risk.

Conoscenze

Professionalism

Self-directed work

Multitasking

Interpersonal skills

Clinical research processes

Formazione

Bachelor's Degree in related field

Descrizione del lavoro

Yale University is seeking a Clinical Trials Office Quality Assurance Analyst in New Haven to support quality management for cancer center clinical trials, focusing on QC, monitoring, and inspection readiness. You will coordinate internal monitoring, track deviations and CAPAs, and support timely follow-up to strengthen data integrity.

The role requires collaboration with investigators, HRPP and IRB, and requires expertise in regulatory knowledge and GCP.