Senior Quality Specialist

05-Apr-2024

Comprehensive Cancer Center - Clinical Trial Operations

87757BR

University Job Title

Senior Quality Specialist

Bargaining Unit

None - Not included in the union (Yale Union Group)

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

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

1. Conducts risk based internal monitoring and quality control reviews of YCC supported studies and YCC research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and CTO and Yale School of Medicine (YSM) policies and procedures.   2. Work with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall quality. 3. Leads the CTO internal monitoring and quality control review effort by mentoring Quality and Education Coordinator & Quality and Educations Specialist in the planning and conduct of monitoring and quality reviews. 4. Develops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and CTO leaders, when issues are detected in order to avoid further deviations or other compliance issues. Also responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectiveness.  5. Coordinates and manages the preparation of all external audits conducted by study sponsors.  6. Collaborates and supports Yale Center for Clinical Investigation (YCCI) Quality Assurance & Monitoring team on regulatory authority (e.g.: FDA, EMA) inspection preparedness for CTO supported trials as needed. 7. Meets with new hires, transfers or promoted staff to review and start Quality Control Checklist.  Monitors task completion and provides feedback over staff’s first 60 days of onboarding in new/transferred/promoted role.   8. Collaborates with the Sr. Training Specialist, clinical and regulatory leadership teams to draft and implement policies, SOPs, and educational opportunities to support quality improvement.  9. Advises the Research Technology Manager on data quality related processes that impact the CTO teams, ensuring smooth and constructive collaboration and communication.  10. Partner with the Sr. Training Specialist to educate and provide guidance to CTO staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice Guidelines.  11. Other duties as assigned.

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

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

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