YCCI Quality Assurance Specialist

Clinical Research Auditor

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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.

Required Skills and Abilities:

• 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.

Principal Responsibilities:

• 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.
• Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.
• Identifies research non-compliance and reports to appropriate leadership within YCCI, Departmental leadership, HRPP, the IRB and the OGC.
• 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.
• 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.
• Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.
• Analyzes protocol to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.
• Assesses audit findings in the context of the larger program to identify trends or program wide areas of in need of improvement or education.
• Assesses the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge.
• Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators. Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities.
• Reports QA findings related to deviations, non-compliance based on very strict reporting regulations.
• Reviews reports/findings from audits with investigators and advises and monitors appropriate action plan.
• Conducts follow-up reviews for compliance with audit recommendations, responding to investigator rationale. Identifies trends in findings to be addressed in educational or corrective actions for specific group of researchers.
• Designs and conducts training programs, makes recommendations for quality improvement and assists in the creation and follow up of corrective action plans based on audit findings.
• Develops and delivers education and training programs to promote safety and compliance for the PI's and all study team members.
• Conducts continuous auditing activities identifying areas of high risk and creates activity reports for ongoing analysis from a medical standpoint. Interviews individuals with specialized knowledge related to an investigation. Identifies areas of concern or heightened medical risk to subjects, investigators, or the University.
• Integration of Data Safety and Monitoring Plans and QA findings with committees and educational plans.

Required Education and Experience:

• Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience. GCP training required within 3 months of hire.