1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned.
Preferred Education: Advanced degree preferred (JD, PhD, MD, etc.). Research Compliance, Certified IRB Professional, or other relevant certification. Project, quality, or lean management certification. Experience in a leadership/consultancy role. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process. Experience with international research standards.
Preferred Education, Experience and Skills: Advanced degree preferred (JD, PhD, MD, etc.). Research Compliance, Certified IRB Professional, or other relevant certification. Project, quality, or lean management certification. Experience in a leadership/consultancy role. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process. Experience with international research standards.
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, e-mail, Outlook, and Adobe, etc.). Knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms).
Posting Position Title: Associate Director 4
Required Skill/ability 3: Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches. Ability to distill and communicate complex information into understandable information.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Assistant Director, Quality Assurance
Required Skill/ability 1: Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.
Required Skill/ability 4: Demonstrated ability to provide guidance regarding regulatory requirements and resolve issues. Ability to be proactive, flexible, and customer service-focused and to work effectively with others. Demonstration of ethics and integrity in professional matters, with sensitivity to confidentiality, and commitment to protecting research participants.
Required Skill/ability 2: Demonstrated ability to manage, organize, and execute complex projects. Ability to multi-task, identify, analyze, and resolve problems efficiently and effectively, to use good, independent judgment and to assess risk. Ability to independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.
Bachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.
Internal Number: 66113BR
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.