Research Regulatory Specialist

Job Description

The Research Regulatory Specialist is responsible for ensuring compliance with federal, state, and institutional regulations governing human subject research. This position will support research teams by overseeing regulatory submissions, maintaining compliance documentation, and ensuring adherence to ethical research practices. The role involves coordinating with investigators, Institutional Review Boards (IRBs), and regulatory agencies to facilitate research approvals and ongoing compliance.

Essential Responsibilities

• Prepare, submit, and track regulatory documents, including IRB applications, amendments, and continuing review reports
• Ensure compliance with federal regulations (e.g., FDA, OHRP), institutional policies, and ethical guidelines
• Serve as a regulatory liaison between investigators, study teams, IRBs, and other regulatory bodies
• Maintain organized and accurate regulatory documentation, including consent forms, training records, and correspondence
• Provide guidance to investigators and study staff regarding regulatory requirements and best practices
• Monitor research activities for compliance and assist in audits or inspections as needed
• Develop and conduct training sessions on regulatory compliance and research ethics
• Stay informed on regulatory changes and advise research teams accordingly

General Responsibilities

Minimum Requirements

Education : Bachelor's Degree required.

Experience : At least 3 years of experience in clinical research required.

License / Certification / Registration Requirements : Certified IRB Professional (CIP) issued by PRIM&R or Certified Clinical Research Professional (CCRP) issued by SOCRA preferred.