Quality and Education Assistant Director
M6 $75,000-$169,600 with sign on bonus potential
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Reporting to the YCC CTO Executive Director, this position utilizes their strong knowledge of clinical research, Good Clinical Practice (GCP), and associated federal and state regulations to develop processes, strategies and initiatives to meet the intensive onboarding, orientation, training, and quality review needs of the CTO. This individual is responsible for the design, coordination and application of onboarding and continuing clinical trial education/training for staff utilizing a standardized, role-based approach. The Assistant Director of Quality and Education, working with faculty leadership, will support new investigator training as well as on-going continuing education for investigators. In addition, this position works collaboratively with CTO leadership, Yale University counterparts, and other stakeholders to develop, validate, revise, organize and implement a quality control program within the YCC CTO. The quality control program’s focus is to identify training gaps and deficiencies, monitor key performance outcomes, improve use of data reporting and technology solutions, and recommend and implement process improvements. The mission of the Quality and Education team is to foster a supportive environment conducive to achieving the Cancer Center’s clinical research mission.
1. Provides direct management and supervision of the Quality and Education team supporting the YCC CTO. 2. In collaboration with YCC CTO Leadership, CTO Operations, develops, implements, and evaluates employee development programs for the CTO. Identifies and recommends opportunities to improve and align systems and works to prepare and enhance staff for the organizational growth needs of the department, supporting the mission of YCC. 3. Develops, implements, and continually assesses the full range of orientation and onboarding offerings, ensuring that new staff and staff new to their role have an effective, standardized, and comprehensive introduction to the work of the CTO, their role-specific functions, and the University. 4. Works in partnership with CTO Leadership, including other Assistant Directors within the CTO to ensure continued education, compliance, coordination, and cohesive communication across all aspects of the CTO. 5. Coordinates with CTO Leadership and YCC disease groups leaders and Yale University to develop and maintain an investigator training program. 6. Leads the conduct of needs assessments to identify gaps in current training programs and processes to drive training initiatives and best in class industry learning opportunities. 7. Oversees the development, execution, and maintenance of training programs that challenge and energize employees while strengthening service levels. 8. Provides consulting to CTO Assistant Directors, Faculty, and Managers regarding team and professional development of staff. 9. Participates in planning and facilitating training and quality updates at CTO staff meetings and CTO leadership meetings. 10. Facilitates and assesses process improvement and standardization across YCC CTO, in conjunction with other Yale University departments and/or affiliates to provide for accurate, compliant, efficient, timely and cost-effective clinical research and clinical care practices. 11. Assesses impact of quality review findings and other identified compliance risks to subject safety, data integrity, and business operations and escalates compliance risks to YCC CTO management and applicable Yale compliance departments, as necessary. 12. In collaboration with other Yale departments, facilitates investigations into significant quality issues, scientific misconduct, and serious breach of Good Clinical Practices; facilitates identification of root cause and development of appropriate corrective and preventive actions; tracks actions and confirms effectiveness; and ensures reporting of potential or confirmed violations to regulatory authorities. 13. Responsible for ensuring Corrective and Preventative Action Plans (CAPAs) developed to address significant quality issues are implemented and monitors to ensure effectiveness. 14. Ensures use of research technology within YCC CTO is aligned to data governance standards necessary for NCI reporting requirements and Leadership needs. 15. Promotes an environment that is conducive to professionalism, ongoing advancement and excellence in practice and identifies opportunities for improvement. 16. Takes on special projects or tasks as directed by the Executive Director of the CTO. 17. Performs other duties as assigned.
Required Education and Experience
Bachelor’s degree in health-related discipline, or other related field. A minimum of eight (8) years of experience in clinical research, five (5) years of experience in research compliance, and three (3) years of supervisory experience.
Required Skill/Ability 1:
Demonstrated mastery of the phases of clinical trials, and the regulatory, administrative, and operational functions necessary to support the clinical research study life cycle in a safe and compliant manner.
Required Skill/Ability 2:
Demonstrated ability to provide proactive, flexible, and customer service focused advice; demonstrate ethics and integrity in a professional manner; demonstrate sensitivity to confidentiality; and a commitment to protecting research participants. Ability to lead and promote collaboration, including the proven ability to work effectively with all team members.
Required Skill/Ability 3:
Demonstrated ability to identify training needs and develop and launch training programs. Expert ability to lead, organize, and execute on multiple complex projects to meet deadlines; multi-task, identify, analyze, and resolve problems efficiently and effectively. Follow through on tasks; prioritize work; and use good judgement and assess risk.
Required Skill/Ability 4:
Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, local and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.
Required Skill/Ability 5:
Demonstrated technology and software application skills; ability to learn new software packages; highly skilled in office productivity software (e.g.: Word, PowerPoint, Excel, email, Adobe Acrobat, etc.); and knowledge of technology platforms used in research (e.g.: IRB management, clinical trial management, and related platforms.
Preferred Education, Experience and Skills:
Oncology clinical research experience strongly preferred. Previous training or precepting experience in a Clinical Research setting.
Preferred Licenses or Certifications:
ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.