Position Focus:

Works closely with faculty and researchers across the university and VA with a focus on COVID-19 clinical trials. Provides expertise in writing SOPs for IND projects ensuring compliance with FDA requirements. Supports COVID-19 research projects, including design, data management, and data analysis. Maintains policies and procedures for ensuring data security and integrity as required by CFR21 Part 11. Develops compliance and progress  reports for COVID-19 clinical trials for submission to FDA. Collaborates with researchers to make data analysis understandable and provides instruction and training on database usage and data analysis techniques as appropriate.

• Works with varied data sources including self-reported questionnaires, ecologic momentary assessment, EHR, claims, VA administrative, etc. YCAS Projects will include assisting with DSMB reporting, as well as working on Veteran Affairs Projects.
• Manages several routine research projects simultaneously and ensures that the design, testing, implementation, and prioritization objectives are met.
• Provides guidance and expertise at all stages of the research process including data management, analysis and visualization.
• Documents database procedures and policies and resolves complex protocol issues in existing databases.
• Works closely with study Principal Investigators to develop detailed data management data and data analysis plans for implementation.
• Works directly with research personnel to identify and resolve technical issues, troubleshoot problems, and create reports. Manage client expectations by communicating directly with staff to understand goals and solve user problems.
• Develops and implements relevant data management procedures and statistical programs to incorporate data from multiple projects and/or sources.
• Creates reports for data quality and facilitate data management meetings with experts within and outside the university.
• Ensures accuracy of data reporting across various analytical tools and multiple data sources; serves as the primary point of contact for questions and queries, troubleshooting, etc.
• In preparation of research grant applications and articles, supplies investigators with expertise pertaining to data management, data analysis, and validity.

Essential Duties

1. Develop and maintain a comprehensive set of metrics to enable departments’ operating oversight and external results reporting. Leverage metrics to identify business opportunities and risks to drive strategic action.
2. Create central databases from existing data currently stored in multiple data sources. Designs comprehensive databases with advance knowledge of relevant applications impacting on the data analyses and reporting.
3. Use advanced statistical knowledge to provide support in managing and analyzing data.  Provide compelling and concise analysis to enable business owners to make well informed decisions regarding options for problem resolution and opportunity realization. 
4. Identify quality issues and prepare root cause analysis and action plans to improve work quality.
5. Contributes in testing and quality assurance process. Collaborates with developers and end-users to ensure that application functionality meets client needs. Tests solutions, problem-solve issues, and coordinate enhancements. 
6. May perform other duties as assigned.

Required Education and Experience

Bachelor’s degree and 3 years of related work experience or an equivalent combination of education and experience.

Required Skill/Ability 1:

Proven experience writing SOPs, and oversight of research projects.

Required Skill/Ability 2:

Demonstrated experience in data management, research studies and methodology, data analysis, and related software applications.

Required Skill/Ability 3:

Well-developed communication skills with the ability to form strong relationships, work in a collaborative environment with the internal stakeholders who have differing quantitative and clinical backgrounds.

Required Skill/Ability 4:

Demonstrated understanding of research protocols as related to study design, data modeling, data collection, data management electronic system design, and statistical analysis with the ability to bring projects to conclusion in a timely manner.

Required Skill/Ability 5:

Proven project management, analytical and organizational skills with the ability to organize and prioritize multiple projects simultaneously.

Weekend Hours Required?

No

Evening Hours Required?

No

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. Please visit www.yale.edu/hronline/careers/screening/faqs.html 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.

Affirmative Action Statement:

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: ocr.boston@ed.gov.

Note

Yale University is a tobacco-free campus