Research Regulatory Specialist - Pediatrics

Summary 

The Research Regulatory Specialist is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing review submissions for human subject research, ensuring compliance with Federal, State, and Institutional Standard Operating Procedures. This role serves as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB to support the successful conduct of research projects. 

Primary Responsibilities  

• Provide primary administrative support for the preparation of IRB documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent documents. Modify documents as needed to meet IRB guidelines and research program requirements. 

• Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports. Review submissions for accuracy, completeness, and compliance using established checklists prior to submission. 

• Support faculty with Investigator-Initiated IND/IDE applications. Maintain IRB and FDA regulatory files for each IND/IDE and ensure required routine monitoring is conducted. 

• Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee. Manage ClinicalTrials.gov postings as required. 

• Collaborate with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs for assigned protocols. 

• Identify and resolve problems or obstacles related to research protocol implementation. Communicate issues to supervisors and study investigators. 

• Ensure all regulatory activities comply with applicable federal and state laws, as well as institutional standard operating procedures. 

• Assist investigators and research staff with the development of program materials, including educational materials, marketing content, websites, forms, and reports. 

• Maintain program timelines by tracking deadlines for program components. Utilize the institution’s Clinical Trial Management System (CTMS) to meet regulatory requirements and track activities. Collect, analyze, and disseminate program data, and report progress to stakeholders. 

• Coordinate notifications to study team members regarding annual regulatory education requirements. 

• Work with principal investigators to develop, implement, and maintain comprehensive databases and files related to the research program. 

• Other duties as assigned. 

Knowledge – Skills – Abilities

• Excellent oral and written communication skills are essential.  

• Strong critical thinking, problem-solving, and attentiveness to detail required.  

• Additional training in regulatory compliance strongly preferred. 

Qualifications 

Appropriate experience may be substituted for education on an equivalent basis.  

Minimum Required Education:  Bachelor’s degree.   

Minimum Required Experience:  2 years in compliance or healthcare field  

Preferred Education:   2 years in compliance or healthcare field 

Required Certification/Licensure(s):   CITI certification required within 30 days of hire 

Preferred Certification/Licensure(s):  SoCRA and ACRP certification preferred. 

Physical Requirements 

Work requires occasionally lifting moderate weight materials, standing, or walking continuously. 

Work Environment 

Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.