Regulatory Affairs Analyst

Yale Regulatory Affairs Analyst

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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

1. 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.

2. Proficient computer skills. Working knowledge of Microsoft Office suite. Ability and desire to learn new computer platforms and software programs.

3. Solution-oriented with ability to work independently. Ability to prioritize tasks with competing deadlines and minimal supervision.

4. 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

1. Demonstrated experience supporting Oncology department.

2. Demonstrated experience as a clinical research analyst supporting regulatory affairs.

Principal Responsibilities

1. 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.

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 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.