Regulatory Affairs Specialist

Regulatory Affairs Specialist I

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The Regulatory Affairs Specialist I is responsible for providing an independent review, analysis and execution of regulatory activities based on knowledge, analysis and interpretation of institutional policies, federal regulations, and Good Clinical Practices (GCP). The Regulatory Affairs Specialist 1 anticipates and tracks changes in regulations and policies governing clinical research. The Regulatory Affairs Specialist 1 autonomously navigates the regulatory review and approval processes for clinical research by compliantly completing institutional, sponsor and federal research requirements. The Regulatory Affairs Specialist 1 provides regulatory expertise and guidance on procedural documentation and reporting requirements related to regulatory affairs. Collaborating directly with investigators, sponsors, and other key stakeholders within Yale CTO, as well as colleagues across the research enterprise, this role participates in the advancement of critical strategic objectives that promote effective, efficient, and compliant management of Cancer Center clinical research studies. The Regulatory Affairs Specialist 1 will independently monitor their workload intensity and track deadlines to ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting requisite metrics for CTO leadership and departmental stakeholders. The Regulatory Affairs Specialist 1 engages critical thinking skills in the application of expert knowledge and experience to achieve desired regulatory outcomes.

Required Skills and Abilities

• Interprets and applies broad knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level.
• 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 and can have an impact to the areas of which they are accountable.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.

Preferred Education, Experience and Skills

• Experience in clinical research in an academic setting preferred.

Preferred Licenses or Certifications

• ACRP (Association of Clinical Research Professionals) / SOCRA (Society of Clinical Research Associates) (or equivalent) certification preferred.

Principal Responsibilities

• Serves as the primary specialist on regulatory affairs processes for clinical research studies.
• Maintains knowledge of changing regulations and policies governing clinical research.
• Manages, implements, and evaluates all aspects of regulatory activities including submissions and responses at time of study initiation, execution/maintenance and close out.
• Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulation, 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.
• Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the 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 action, 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 plan.
• 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.
• Monitors, interprets, applies, and communicates federal and state regulations, and local policies for new guidance, updates, or policies.
• 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.
• Performs other duties as assigned.

Required Education and Experience

• Bachelor's degree in life sciences or other health related discipline required and a minimum of two (2) years of clinical research support experience.

Required License(s) or Certification(s)

• 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.