What are the responsibilities and job description for the Research Regulatory Specialist position at The Dean A. McGee Eye Ins?
Summary
The Research Regulatory Specialist is responsible for ensuring compliance with federal, state, and institutional regulations governing human subjects 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 Functions
- 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
Experience
- Experience in regulatory compliance, IRB administration, or human subjects research preferred
- Knowledge of federal research regulations, including 21 CFR Part 50 & 56, 45 CFR 46, and ICH-GCP guidelines
- 2 years of prior experience in research compliance, regulatory affairs, or IRB administration preferred, but not required
Education Requirements
- Bachelor’s degree in a relevant field (e.g., life sciences, public health, regulatory affairs)
- Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP) preferred
Competencies/Skills Required
- Strong attention to detail and ability to manage multiple projects simultaneously
- Excellent communication and interpersonal skills
- Proficiency in Microsoft Office and experience with electronic regulatory systems
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand, walk; sit; use hands to finger, handle, or feel objects, tools of controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk of hear; and taste or smell. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
AAP/EEO Statement
The Dean McGee Eye Institute is an Equal Opportunity, Affirmative Action M/F/V/D employer.
Other Duties
Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
