Clinical Trials Office Quality Assurance Analyst

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Overview

Reporting to the Manager of Quality and Education, the incumbent supports quality management activities for clinical trials conducted within the YCC Clinical Trials Office (CTO), with a primary focus on quality control, routine monitoring support, and audit/inspection readiness.

The incumbent will coordinate internal monitoring activities and documentation, track and trend quality findings (including data delinquency indicators), and support timely follow-up and closure of deviations and CAPAs, including effectiveness checks, to strengthen compliance and data integrity.

The mission of the Quality and Education team is to foster a supportive environment conducive to achieving the Cancer Center’s clinical research mission by promoting consistent, proactive, and inspection-ready clinical research practices that protect participants and support high-quality data.

Essential Duties of the Position

Works directly and in collaboration with 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 YCC CTO.

Analyzes protocols to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.

Assesses the risk and stratify the study from a QC/regulatory compliance perspective based on clinical research experience and regulatory knowledge.

Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and ICH Good Clinical Practice.

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 review findings related to deviations; non-compliance based on very strict reporting regulations.

Identifies research non-compliance and reports to appropriate leadership within YCC CTO.

Identifies and develops recommendations for changes that ensure the fulfillment of compliance requirements. Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

Maintain oversight during an FDA inspection or other internal or external audit. Provides educational and corrective action advice to faculty in preparation for FDA audits.

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.

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.

Develops education and training programs to promote safety and compliance for the PI's and all study team members.

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.

Required Skills and Abilities

1. Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.

2. Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule.

3. Organized and capable of handling multiple/diverse projects simultaneously.

4. Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.

5. Demonstrable understanding of clinical research processes and procedures from study start-up to study close out.

• Preferred Skills and Abilities
• 1. SOCRA/ACRP (or equivalent) certification
• 2. Master's Degree in related field
• Principal Responsibilities

1. Works directly and in collaboration with YCC CTO 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 YCC CTO.

2. Analyzes protocols to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.

3. Assesses the risk and stratify the study from a QC/regulatory compliance perspective based on clinical research experience and regulatory knowledge.

4. Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and ICH Good Clinical Practice.

5. 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.

6. Reports review findings related to deviations; non-compliance based on very strict reporting regulations.

7. Identifies research non-compliance and reports to appropriate leadership within YCC CTO.

8. Identifies and develops recommendations for changes that ensure the fulfillment of compliance requirements. Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

9. Maintain oversight during an FDA inspection or other internal or external audit. Provides educational and corrective action advice to faculty in preparation for FDA audits.

10. Reviews reports/findings from audits with investigators and advises and monitors appropriate action plan.

11. 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.

12. 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.

13. Develops education and training programs to promote safety and compliance for the PI's and all study team members.

14. 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.

Required Education and Experience

1. Bachelor’s Degree in related field and five years of related experience or an equivalent combination of education and experience.

2. Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes

3. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.

4. Advance knowledge of auditing and monitoring techniques and practices.

Job Posting Date

10/23/2026

Job Category

Professional

Bargaining Unit

NON