Regulatory Affairs Analyst

Yale University; New Haven (CT); Sur place; USD 55 000 - 85 000; Plein temps

Résumé du poste

Yale University in New Haven is seeking a Regulatory Affairs Analyst to support regulatory activities for the Gynecologic Oncology CTO portfolio, including protocol submissions, continuing reviews, and training records.

You will partner with investigators, staff, sponsors, and auditors to ensure compliance, maintain regulatory files, and communicate regulatory matters clearly across teams.

Qualifications

• Experience with IRB protocols and submissions.
• Professional verbal and written communication skills.
• Proficient in Microsoft Office; willing to learn new platforms.

Responsabilités

• Collaborate with investigators and study teams to consult and identify trial objectives.
• Interpret research needs and translate them into application and operational requirements.
• Critically evaluate information from protocols, budgets and agreements to reconcile conflicts.
• Analyze data and develop reporting modules, ad-hoc analyses and related tools.
• Develop and maintain documentation and libraries on key processes.
• Assess risk and ensure compliance with protocols, university procedures and third-party regulations.
• Determine training needs and conduct training sessions with study teams.

Connaissances

IRB submissions

Verbal & written communication

Microsoft Office

Independent work

Time management

Multi-project handling

Formation

Bachelor’s degree in related field

Description du poste

Department: Obstetrics & Gynecology - Clinical Division Administration

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!

Overview

The Regulatory Affairs Analyst provides regulatory affairs support related to the conduct of clinical trials in the Gynecologic Oncology Division Clinical Trials Office (CTO), Department of Obstetrics, Gynecology & Reproductive Sciences. Responsible for assisting with the set-up, activation, and ongoing support of all trial types in the CTO research portfolio, including investigator-initiated, federally funded, and industry-sponsored protocols. Activities supported by regulatory affairs include, but may not be limited to: preparation and submission of initial protocol, amendment, and continuing review submissions to the Protocol Review Committee, IRB, and ancillary committees; tracking evidence of protocol and IRB-required training for all research staff; maintenance and sharing of regulatory files with study sponsor monitors, auditors and inspectors to ensure compliance with protocol requirements, university and applicable authorities; receipt and tracking of safety reports; collaborating with CTO staff, laboratory and pharmacy staff regarding study status changes; and serving as a liaison between the CTO, research staff and study sponsor when communicating regulatory matters.

Required Skills and Abilities

• 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.

Preferred Skills and Abilities

• Demonstrated experience supporting Oncology department.
• Demonstrated experience as a clinical research analyst supporting regulatory affairs.

Principal 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.
• Assess 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.

Required Education and Experience

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.

Job Posting Date

10/15/2026

Job Category

Professional

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (21)

Salary Range

$55,000.00 - $85,000.00

Benefits

A general description of the benefits to be offered with this Managerial & Professional position is available at: Yale Benefits

Time Type

Full time

Duration Type

Staff

Work Model

On-site

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 basedon 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.

Health Requirements

Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.

Note

Yale University is a tobacco-free campus.

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