Regulatory Affairs Analyst

Yale University’s Regulatory Affairs Analyst supports clinical trials in the Gynecologic Oncology Division Clinical Trials Office. The role assists with trial setup and ongoing regulatory support, including protocol and IRB submissions, documentation, compliance, safety reporting, and coordination with study teams and sponsors.

Responsibilities

Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters

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

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

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

Develops and maintain documentation and libraries on key processes

Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations

Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members

Performs or assists with research compliance audits or self-assessments

Communicates effectively the perspective of business opportunities, needs, and risks

Preferred

Demonstrated experience supporting Oncology department

Demonstrated experience as a clinical research analyst supporting regulatory affairs

Oncology Department Support

Clinical Research Analysis

Regulatory Affairs

Company

Research university focused on education and knowledge advancement

New Haven, Connecticut, USA

https://www.yale.edu/

Founded in 1701

10001+ employees

Qualifications

Demonstrated experience and understanding with IRB protocols and submissions

Professional verbal and written communication skills

Capacity for knowledge sharing and ability to communicate complex ideas across cross-functional teams

Proficient computer skills

Working knowledge of Microsoft Office suite

Ability and desire to learn new computer platforms and software programs

Solution-oriented with ability to work independently

Ability to prioritize tasks with competing deadlines and minimal supervision

Maintains attention to detail in a fast-paced team environment with strong organizational and time management abilities

Ability to manage multiple concurrent projects while balancing priorities and timelines

Bachelor's degree in a related field and one year 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

Demonstrated experience supporting Oncology department

Demonstrated experience as a clinical research analyst supporting regulatory affairs

Bachelor’s degree in a related field and one year of related work experience in the same job family or an equivalent combination of experience and education.

Required skills

IRB Protocols and Submissions, Microsoft Office, Oncology Research, Clinical Research Regulatory Affairs, Regional and Federal Regulations

Preferred skills

Demonstrated experience supporting Oncology department, Glassdoor, 4.2, New Haven, Connecticut, USA, https://www.yale.edu, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Represents job field similar to this job, Legal and Compliance, Engineering and Development, Education and Training, Customer Service and Support, Management and Executive, Arts and Entertainment, Human Resources, Accounting and Finance, Sales, Creatives and Design, Public Sector and Government, Marketing, Trends of Total Sponsorships, *2026, (287), 2025, (328), 2024, (413), 2023, (188)

Experience

1+ years