Regulatory Specialist

Division: allied research institute
Reports To: Vice President of Research

Employment Type: Independent Contractor

Position Summary

The Regulatory Specialist is responsible for managing and maintaining the regulatory documentation and compliance requirements for clinical research studies, clinical trials, and other human subjects research projects. This position supports study start-up, IRB submissions, regulatory binders, essential document management, protocol amendments, continuing reviews, reportable events, staff training documentation, and audit readiness.

The Regulatory Specialist ensures that research studies are conducted in compliance with applicable regulatory standards, sponsor requirements, IRB expectations, organizational policies, and ethical standards for human subjects protection.

Essential Duties and Responsibilities

Regulatory Study Start-Up

• Review study protocols, consent forms, investigator brochures, manuals of procedures, and sponsor materials.

• Prepare and coordinate regulatory documents required for study activation.

• Assist with site feasibility, start-up checklists, regulatory document collection, and study readiness.

• Develop and maintain regulatory binders or electronic regulatory files for assigned studies.

• Ensure required approvals are obtained before study activities begin.

IRB Submissions and Maintenance

• Prepare, submit, and track IRB applications, amendments, continuing reviews, reportable events, and study closures.

• Maintain current IRB approvals, consent forms, recruitment materials, and protocol documents.

• Track submission deadlines and ensure timely completion of continuing reviews and renewals.

• Communicate with IRBs, investigators, sponsors, and internal research staff regarding submission status and required changes.

• Ensure that approved consent forms and participant-facing materials are current and appropriately version-controlled.

Regulatory Documentation and Essential Files

• Maintain complete, accurate, and inspection-ready regulatory files for all assigned studies.

• Track and update essential documents, including:

  • Protocols and amendments

  • IRB approvals

  • Informed consent documents

  • Investigator credentials

  • Training documentation

  • Delegation of authority logs

  • Financial disclosure forms

  • Laboratory certifications, if applicable

  • Correspondence with sponsors, IRBs, and monitors

• Ensure document version control and appropriate filing of superseded documents.

Compliance Monitoring and Audit Readiness

• Support internal quality checks of regulatory files and study documentation.

• Prepare for sponsor monitoring visits, IRB audits, FDA inspections, or internal compliance reviews.

• Assist in responding to monitor findings, audit observations, and corrective action requests.

• Track protocol deviations, noncompliance issues, reportable events, and regulatory follow-up.

• Support corrective and preventive action documentation when needed.

Training and Staff Documentation

• Track required research staff training, including Good Clinical Practice, human subjects protection, protocol-specific training, and study-specific certifications.

• Maintain delegation of authority logs and ensure that staff perform only delegated study responsibilities.

• Assist with onboarding research staff to study-specific regulatory requirements.

• Notify leadership when required documentation, licenses, certifications, or trainings are expired or incomplete.

Policy, Process, and Communication Support

• Assist in developing and maintaining research regulatory SOPs, templates, trackers, and workflows.

• Communicate regulatory requirements to study teams in a clear and practical manner.

• Serve as a liaison among investigators, research coordinators, sponsors, IRBs, monitors, and organizational leadership.

• Participate in study team meetings and provide updates on regulatory status, outstanding documents, and upcoming deadlines.

• Support a culture of compliance, research integrity, and participant protection.

Required Qualifications

• Bachelor’s degree in health sciences, public health, healthcare administration, regulatory affairs, life sciences, or related field preferred.

• Experience in clinical research, regulatory affairs, compliance, IRB coordination, or healthcare administration.

• Knowledge of human subjects research protections, IRB processes, informed consent, and regulatory documentation.

• Strong organizational and document management skills.

• High attention to detail and ability to manage multiple deadlines.

• Strong written and verbal communication skills.

• Proficiency with Microsoft Office, Adobe, shared drives, electronic regulatory systems, and document tracking tools.

Preferred Qualifications

• Experience in clinical trials, academic research, FQHC-based research, or community-based research.

• Familiarity with FDA regulations, Good Clinical Practice, HIPAA, and institutional review board requirements.

• Experience with electronic regulatory platforms or IRB systems.

• Regulatory Affairs Certification, Certified IRB Professional, or clinical research certification preferred but not required.

• Experience preparing for sponsor monitoring visits, IRB audits, or regulatory inspections.

Key Competencies

• Regulatory accuracy

• Ethical judgment

• Confidentiality

• Deadline management

• Document control

• Compliance orientation

• Clear communication

• Audit readiness

• Problem-solving