Oncology Clinical Trial Quality Assurance

NOTE: THIS IS A HYBRID POSITION-Must be able to commute to New Haven CT
Reporting to the Director of Quality and Education, the incumbent conducts clinical research auditing and quality control efforts for Clinical Trials conducted.

Essential Duties

1. Works directly and in collaboration with leadership,

• Departmental leaders, investigators, research staff to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of Clinical Trials.

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.

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.

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.

Preferred Education, Experience and Skills:

SOCRA/ACRP (or equivalent) certification. Master’s Degree in related field.