University Job Title
Clinical Research Analyst 1
Bargaining Unit
None - Not included in the union (Yale Union Group)
Compensation Grade
Administration & Operations
Compensation Grade Profile
Supervisor; Senior Associate (22)
Wage Ranges
Click here to see our Wage Ranges
Searchable Job Family
Research Res 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
2 Church Street South Doctor's Building
New Haven, CT 06519
Position Focus:
Using knowledge of research gained through experience working in a research setting provides business understanding and analytics on specific projects or sections of projects to Clinical Research study teams to ensure compliance with research regulations, policies, and procedures for clinical research trials throughout the university as well as in affiliated locations, such as YNHH, YM, and Community practices and events.
Essential Duties
1. Works closely with investigators and other study team members including the project manager, for projects or programs of a small to medium size or sections of larger projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters. 2. Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements. 3. Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials. 4. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases 5. Develops and maintain documentation and libraries on key processes. 6. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. 7. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members. 8. Performs or assists with research compliance audits or self-assessments. 9. Communicates effectively the perspective of business opportunities, needs, and risks.
Required Education and Experience
Bachelor’s degree in a related field and two years of related work experience in the same job family or an equivalent combination of experience and education. Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis; Epic, OnCOre, tele and video consenting.
Required Skill/Ability 1:
Proven demonstrated ability in EMR’s and electronic data capture systems for clinical trial management including telehealth and/or Video Visit application.
Required Skill/Ability 2:
Ability to provide direction to investigators to strengthen their research and ensure regulatory, protocol, and research billing compliance.
Required Skill/Ability 3:
Ability to provide required recruitment and resource information for assigned projects, grant applications and/or industry feasibility and qualification requirements.
Required Skill/Ability 4:
Ability to independently manage multiple small to medium-sized human subject projects as well as contribute to overall clinical research recruitment across all disciplines.
Required Skill/Ability 5:
Proven ability to effectively communicate in English and Spanish, with human subject volunteers while demonstrating adherence to the standard practices of consent, retention, and deployment of e-applications required for study participation.
Preferred Education, Experience and Skills:
GCP; Willing to obtain SoCRA certification within one year of hire.
Required Licenses or Certifications
GCP; Willing to obtain SoCRA certification within one year of hire.
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
Thank you for your interest in employment at Yale University. Please also note that the university has a COVID-19 vaccination and booster requirement for all students, staff & faculty which is described in the COVID-19 Vaccine Program. As you search our open positions, you will see that all postings list their on-site addresses which gives more detail on the on-campus work location of the role.
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).
W.L. Harkness Hall, 3rd Floor, Room 303
100 Wall Street, New Haven CT 06511
203-432-0849
equity@yale.edu
Note
Yale University is a tobacco-free campus