University Job Title
Senior Quality Specialist **
Bargaining Unit**
None - Not included in the union (Yale Union Group) **
Time Type**
Full time **
Duration Type**
Regular **
Compensation Grade**
Administration & Operations **
Compensation Grade Profile**
Manager; Program Leader (P5) **
Wage Ranges**
Click here to see our Wage Ranges **
Searchable Job Family**
Clinical, Research Res Support, Research/Support **
Total # of hours to be worked:**
37.5 **
Work Week**
Standard (M-F equal number of hours per day) **
Work Location**
Medical School Campus **
Worksite Address**
221 Whitney Ave
New Haven, CT 06511 **
Work Model**
Remote **
Position Focus**
The Senior Quality Specialist in the Yale Cancer Center (YCC) Clinical Trials Office (CTO) reports to the Director of Quality and Education.
The Sr. Quality Specialist is responsible for assessing the quality of clinical trials conducted within the Yale Cancer Center (YCC). This position participates in all aspects of CTO clinical research integrity, compliance and privacy initiatives, including workforce orientation, incident response and documentation, clinical research monitoring and quality reviews, CTO staff education on clinical research compliance topics, and providing support for policy and procedure development.
The mission of the Quality and Education team is to foster a supportive environment conducive to achieving the Cancer Center’s clinical research mission. **
Essential Duties**
Required Education And Experience
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. **
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, Experience And Skills**
Oncology clinical research experience strongly preferred. Preferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systems. **
Preferred Licenses Or Certifications**
SOCRA/ACRP (or equivalent) certification. **
Weekend Hours Required?**
Occasional **
Evening Hours Required?**
Occasional **
Drug Screen**
No **
Health Screening**
No **
Background Check Requirements**
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. **
COVID-19 Vaccine Requirement**
Required
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines **
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. **
EEO Statement**
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). **
Note**
Yale University is a tobacco-free campus
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