Assistant Director, Quality Assurance at Joulé

Title:  Assistant Director, Quality Assurance
Location:  New Haven, CT
Duration:  Contract to Hire
Schedule:  M-F 37.5 hours, occasional weekend and evening hours
Target Start Date:  ASAP

Responsibilities:

• Leading, managing, and advising designated staff, teams, and/or areas and is responsible for independently identifying and resolving issues 
• Ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact human research.
• Review, research, and interpret changes, trends and new developments related to human research. Provide written analysis on specified topics.
• Draft policies and procedures to implement and operationalize initiatives.
• Develop strategies to enable Departments and personnel to successfully adapt to changes.
• Serve as a resource regarding human research matters.
• Reporting jointly to the Associate Director, Quality Assurance, manages the development, implementation and monitoring of an effective clinical research quality assurance program, coordinating the clinical research reviews and monitoring efforts for clinical trials conducted 

Requirements:

• Advanced degree preferred (JD, PhD, MD, etc.).
• Min Bachelor's Degree in related field and eight years of experience or an equivalent combination of 
• 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.
• 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.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
 

Company:JouléLocation:Connecticut - United StatesJob Types:ContractPost Date:October 22, 2021Valid Through:November 21, 2021

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