Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist I at Yale contributes to the institution's mission of advancing cancer research through independent review and execution of regulatory activities, tracking changes in regulations, and ensuring compliance with FDA guidelines, GCP, and institutional policies.

Responsibilities

• Maintains knowledge of changing regulations and policies governing clinical research.
• Manages, implements, and evaluates all aspects of regulatory activities including submissions and responses at study initiation, execution/maintenance, and close out.
• Creates reports and recommendations based on analysis of protocols and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes.
• Ensures study protocol submissions, reviews, and reporting requirements are met per ICH/GCP, applicable federal regulations, and institutional and sponsor policies and procedures.
• Maintains regulatory documentation to substantiate essential documents for clinical research trials.
• Identifies instances of noncompliance and deviations from the protocol and regulatory requirements, evaluates each instance to determine appropriate corrective and preventative actions, and compiles information to draft reports to the appropriate parties and committees.
• Collaborates with Investigators and Regulatory Managers in the preparation and execution of corrective and preventative action plans and ensures implementation and adherence to stated plans.
• Provides feedback to the Quality Education Unit to contribute to the design of Regulatory Specialists trainings and continuing education.
• Initiates preparation for interim monitoring visits, internal audits, and external audits/inspections for complex clinical research studies.
• Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards.
• Prepares written documentation as required by the profession and the department; maintains, distributes, analyzes, and projects information for required records, reports, and statistics as directed.

Requirements

• Bachelor’s degree in life sciences or other health-related discipline required.
• A minimum of two (2) years of clinical research support experience.
• Ability to interpret and apply broad knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures.
• Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.
• Advanced oral and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.
• Independent worker with ability to multi-task and remain focused in a fast-paced environment.
• Takes initiative to plan, research, and manage complex studies using advanced understanding of clinical research processes across the study lifespan.
• Works under minimal supervision and understands when to inform others of developments or issues with a specific study.
• Analytical in nature and assignments involve a significant degree of complexity.
• Decisions are guided by various factors including expertise, context, independent judgment, and clear to obscure guidelines and policies.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.) and Internet skills.

Preferred Skills And Abilities

• Experience in clinical research in an academic setting preferred.
• ACRP (Association of Clinical Research Professionals) / SOCRA (Society of Clinical Research Associates) certification preferred.