Director, Quality Assurance

New Haven, New Haven County
Apr 24, 2014
Executive Administration Jobs
C-Level & Executive Directors
STARS Requisition number 24422BR

Department Yale Ctr For Clin Inv

University Job Title Director 3

Posting Position Title Director, Quality Assurance

Bargaining Unit None

Job Category Managerial & Professional

Type of Employment Full Time

Duration Type Regular

Salary Grade 28

Work Location Medical School Campus

Worksite Address 157 Church

Work Week Standard (M-F equal number of hours per day)

Position Focus: The Associate Director of Quality Assurance will design, develop, implement and monitor an effective clinical research quality assurance program coordinating clinical research review and monitoring. The position oversees the administration of multiple oversight committees, an internal auditing program and the implementation of quality control measures to assure safety and compliance. A critical component of the Director's role is to identify to senior leadership safety and compliance concerns and recommend solutions to improve the overall operations, the safe and efficient conduct of clinical trials and educational and training opportunities for faculty and staff. Designs, implements and oversees a Quality Assurance Program for clinical research conducted under the auspices of YCCI that is consistent with federal and state regulations and mandates from the NCI, CTSA and the policies and procedures of the Yale School of Medicine. Develops and oversees implementation of operational policies and procedures for conducting all aspects of quality assurance internal audits and monitoring of clinical research conducted at Yale and at collaborating, affiliate and satellite centers; thereby ensuring compliance with federal regulations and university polices governing the conduct of human subject's research. Establishes a Data and Safety Monitoring Plan for YCCI studies, including guidelines for risk analysis specific to type of study. Oversees implementation and maintenance of Data and Safety Monitoring Plans consistent with university policies ensuring a QA program that is well integrated into the other School of Medicine departments and offices, such as the Office of the Provost, Grants and Contracts and the HIC.

Principal Responsibilities
1. Directs one or more functional areas within an administrative department of the University and ensure compliance with University policies and procedures.
2. Directs analytic and research support for educational policies and planning and develops and approves administrative policies affecting assigned functional areas of the University.
3. Directs and establishes parameters for major projects for the department and University.
4. Interprets federal policies and regulations and educates staff and administration about regulations, restrictions, and the legal responsibilities of the University.
5. Directs and implements policy and program modifications and develops standards to ensure compliance with federal, state and local regulations.
6. Develops and administers an operating budget for the assigned department consistent with University policies and procedures.
7. Develops cost savings objectives and goals; authorizes major purchases and negotiates contracts that range from routine to complex in nature.
8. Establishes and implements long- and short-range goals for the functional area consistent with University goals and objectives.
9. Directs the development of related automated systems to support the function; determines office policies and procedures for use of automated systems.
10. Directs the evaluation and selection of vendors and negotiates contract details including work steps and pricing with the vendors on behalf of the assigned functional area.
11. Works with internal and external contacts to solve problems that range from routine to complex in nature.
12. Represents the University in discussions and negotiations with various governmental agencies.
13. Directs a staff of exempt and nonexempt employees.
14. May perform other duties as assigned.Required Education and Experience
Bachelor's Degree in related field.
Seven years of experience or an equivalent combination of education and experience.

Required Skill/Ability 1: Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.

Required Skill/Ability 2: Advanced knowledge of auditing and monitoring techniques and practices; experience serving on protocol review committees or IRBs. Demonstrated ability to write original reports, assessments and evaluations related to medical/legal issues and ethical concerns related to human subject research.

Required Skill/Ability 3: Proficiency with software tools such as Microsoft Word, Access and Excel.

Required Skill/Ability 4: Proven ability to work in complex environment with multiple avenues for reporting and responsibilities. Excellent verbal and written communication skills. Excellent interpersonal skills and demonstrated ability to work with senior leadership and administration.

Required Skill/Ability 5: Highly motivated, able to work independently and able to take initiative and problem solve. Demonstrated leadership ability. Detail oriented with well developed organizational, managerial and communication skills. Knowledge of human resource practices and principles.

Preferred Education, Experience and Skills: Masters degree and 10 to 15 years experience in clinical research in an academic setting. At least five years experience in quality assurance programs for clinical research. Comprehensive understanding of Yale School of Medicine approval processes and Data Safety Monitoring policies. Experience in a National Cancer Institute designated Cancer Center.

Weekend Hours Required? Occasional

Evening Hours Required? Occasional

Drug Screen No

Health Screening No

Background Check Requirements All external candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle and credit checks based on the position description and job requirements. All offers are contingent on successful completion of a background check. Please visit for additional information on the background check requirements and process.

Posting Disclaimer The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.

Yale University is an affirmative action/equal opportunity employer. Yale values diversity in its faculty, staff, and students and strongly encourages applications from women and members of underrepresented minority groups.