YCCI Quality Assurance Specialist

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Reporting to the Yale Center for Clinical Investigation (YCCI) Quality Assurance Audit Manager, the incumbent conducts clinical research auditing and quality improvement efforts for human subject research conducted at the Yale School of Medicine. This role is critical in ensuring compliance with all applicable regulations, guidelines, and institutional policies, maintaining the highest standards of quality and integrity. The ideal candidate will have a strong background in clinical research and regulatory compliance.

Prior auditing or monitoring experience is preferred. The position may require occasional travel to research sites. Flexible work hours may be necessary to accommodate audit schedules.

The mission of the Office of Quality Assurance (QA) within YCCI is to foster a supportive environment conducive to achieving Yale’s clinical research mission and provide a central resource to aid investigators, research groups and leadership with respect to protocol development, execution, and oversight.

• Demonstrated knowledge and ability to apply ICH GCP guidelines. Demonstrated knowledge and ability to interpret Federal Regulations governing human subject research. Demonstrated ability to be detail oriented while still seeing the "big picture" within the context of a solution-oriented approach to issues.
• Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule. Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.
• Organized and capable of handling multiple/diverse projects simultaneously. Strong critical thinking and problem solving abilities.
• Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
• Demonstrated understanding of clinical research processes and procedures from study start-up to study close out.

• Master’s Degree in a related field.
• Demonstrated knowledge of quality assurance auditing and monitoring techniques and practices.
• SOCRA/ACRP (or equivalent) certification.

• Works directly and in collaboration with YCCI leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions.
  2. Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.
  3. Identifies research non-compliance and reports to appropriate leadership within YCCI, Departmental leadership, HRPP, the IRB and the OGC. 4. Provides educational and corrective action advice to faculty in preparation for FDA audits. Serves as liaison between the investigator, the research team and the FDA during an actual inspection. Records proceedings and summarizes inspection activity in real time.
  5. Consults to investigators needing data safety monitoring plan details/information for their grant application. Develops Data and Safety Monitoring Plans based on the risk assignment categories.
  6. Provides direction to investigators to…