Regulatory Coordinator

Jobtailor; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Jobtailor in Madison, WI seeks a Regulatory Compliance Specialist to support pediatric research studies. You will review regulatory documents, ensure adherence to frameworks, and guide study teams on compliance. The role involves preparing consent materials and communicating with protocol sponsors.

Ideal candidates will have strong communication, organizational, and problem-solving skills, plus experience with IRB submissions and regulatory systems like REDCap or OnCore.

Qualifications

• Bachelor's degree preferred in a relevant field.
• Experience with Institutional Review Board submissions preferred.
• Effective oral and written communication is required.
• Ability to manage multiple projects with strong attention to detail.
• Experience with IRB-related systems (REDCap/ARROW/OnCore) is advantageous.

Responsibilities

• Provide regulatory support for research studies in the Department of Pediatrics.
• Review documents, applications, agreements, and reports for compliance.
• Ensure adherence to regulatory frameworks, laws, and standards.
• Apply regulatory skills across study types and identify escalation needs.
• Perform quality checks and potentially train staff.
• Develop new team and unit processes, procedures, tools, and training.
• Guide research teams on policy and regulatory compliance.
• Communicate with protocol sponsors about regulatory activities.
• Maintain complete regulatory files and records.
• Serve as regulatory contact for human-subjects research.
• Develop clear informed consent documents.
• Prepare and submit protocol-specific materials to IRB and scientific review committees

Skills

Communication

Problem-solving

Attention to detail

Organizational skills

Prioritization

Service-oriented

Independent thinking

Analytical skills

Education

Bachelor's degree preferred

Tools

REDCap

ARROW

OnCore

HealthLink

Microsoft Office Suite

Adobe Acrobat

Google Drive

Box

Job description

• Provide regulatory support for research studies in the Department of Pediatrics


• Review documents, applications, agreements, and reports


• Ensure compliance with internal and external regulatory frameworks, regulations, laws, and standards


• Apply regulatory skills across different types of studies, navigate resources, and identify issues for escalation


• Perform quality checks and potentially train staff


• Develop new team and unit processes, procedures, tools, and training


• Provide guidance to research teams regarding compliance with policies, procedures, and regulations


• Communicate directly with protocol sponsors about regulatory documents and activities


• Maintain complete and accurate regulatory files and records


• Serve as the regulatory contact for human-subjects research studies


• Develop clear and accurate informed consent documents


• Prepare and submit protocol-specific application materials to the Institutional Review Board and scientific review committee

Requirements

• Effective oral and written communication skills


• Independent problem-solving and analytical skills


• Attention to detail and organization


• Prioritization skills and ability to manage multiple projects


• In-depth understanding of, or willingness and ability to learn, clinical research principles and study and institutional guidelines


• Ability to support investigators and study teams with a service-oriented approach


• Experience with Institutional Review Board submissions or equivalent submissions preferred


• Experience with human subjects research preferred


• Experience with REDCap, ARROW, electronic IRB systems, OnCore, HealthLink, Microsoft Office Suite, Adobe Acrobat, and file-sharing systems such as Google Drive or Box preferred


• Bachelor's degree preferred


• Cover letter required


• Resume required


• Continuous eligibility to work in the United States without employer sponsorship


• Ability to provide proof of work authorization and eligibility to work


• Employment may require a criminal background check


• References may be requested from final candidates

Core Competencies

Demonstrates expertise in regulatory compliance for human-subjects research, including the preparation and submission of Institutional Review Board applications. Proficient in developing processes and providing guidance to research teams while ensuring adherence to clinical research principles and standards.

Highest-signal resume keywords

• Regulatory Compliance


• Institutional Review Board Submissions


• Human Subjects Research


• REDCap


• Analytical Skills

ATS Optimization Keywords

Hard Skills

• Regulatory Support


• Quality Checks


• Document Review


• Informed Consent Development


• Protocol-Specific Applications

Soft Skills

• Effective Communication


• Problem-Solving


• Attention to Detail


• Organizational Skills


• Service-Oriented Approach

Industry Keywords

• Clinical Research Principles


• Regulatory Frameworks


• Compliance Standards


• Research Studies


• Research Teams

Tools & Technologies

• REDCap


• ARROW


• OnCore


• HealthLink


• Microsoft Office Suite


• Adobe Acrobat


• Google Drive


• Box