1. Conducts risk based internal monitoring and quality control reviews of YCC supported studies and YCC research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and CTO and Yale School of Medicine (YSM) policies and procedures. 2. Work with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall quality. 3. Leads the CTO internal monitoring and quality control review effort by mentoring Quality and Education Coordinator & Quality and Educations Specialist in the planning and conduct of monitoring and quality reviews. 4. Develops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and CTO leaders, when issues are detected in order to avoid further deviations or other compliance issues. Also responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectiveness. 5. Coordinates and manages the preparation of all external audits conducted by study sponsors. 6. Collaborates and supports Yale Center for Clinical Investigation (YCCI) Quality Assurance & Monitoring team on regulatory authority (e.g.: FDA, EMA) inspection preparedness for CTO supported trials as needed. 7. Meets with new hires, transfers or promoted staff to review and start Quality Control Checklist. Monitors task completion and provides feedback over staff's first 60 days of onboarding in new/transferred/promoted role. 8. Collaborates with the Sr. Training Specialist, clinical and regulatory leadership teams to draft and implement policies, SOPs, and educational opportunities to support quality improvement. 9. Advises the Research Technology Manager on data quality related processes that impact the CTO teams, ensuring smooth and constructive collaboration and communication. 10. Partner with the Sr. Training Specialist to educate and provide guidance to CTO staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice Guidelines. 11. Other duties as assigned.
Required Skill/ability 1: Demonstrated mastery of human subjects research related standards and ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic & industry trends, and other standards. Demonstrable understanding of clinical research review, approval & monitoring processes from start-up to close-out.
Required Skill/ability 2: Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
Required Skill/ability 3: Ability to assess and resolve unprecedented problems that require research and review of policy, procedures, and regulations.
Required Skill/ability 4: Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders. Ability to champion change and identify and execute process improvements.
Required Skill/ability 5: Organized with the ability to handle multiple/diverse projects simultaneously. Proven ability to multi-task and remain focused in a fast-paced environment.
Preferred Education: Oncology clinical research experience strongly preferred. Preferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systems.
Work Week: Standard (M-F equal number of hours per day)
Posting Position Title: Senior Quality Specialist
University Job Title: Senior Quality Specialist
Preferred Education, Experience and Skills: Oncology clinical research experience strongly preferred. Preferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systems. Bachelor's Degree in degree in a health-related discipline, or other related field, and a minimum 5 years' experience working in a clinical research environment, or an equivalent combination of education and related experience. About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.
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