Regulatory Specialist

allied executive solutions

. Manage and maintain regulatory documentation and compliance requirements for clinical research studies, clinical trials, and human subjects research projects .

Posted 9/18/2026contractNew Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory documentation and compliance for clinical research, including IRB processes and human subjects protections. Proficient in maintaining inspection-ready files and supporting internal quality checks and audits.

Highest-signal resume keywords

Regulatory Documentation ManagementIRB CoordinationClinical Research ComplianceDocument Management SkillsFDA Regulations Familiarity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRegulatory AffairsIRB ProcessesInformed ConsentDocument TrackingRegulatory BindersQuality ChecksAudit PreparationResearch SOPsHuman Subjects Research Protections

Soft Skills

Strong Organizational SkillsHigh Attention to DetailEffective CommunicationAbility to Work Respectfully with Diverse CommunitiesAbility to Manage Multiple Deadlines

Tools & Technologies

Microsoft OfficeAdobeElectronic Regulatory SystemsDocument Tracking ToolsShared Drives

Certifications & Qualifications

Regulatory Affairs CertificationCertified IRB ProfessionalClinical Research Certification

Industry Keywords

Good Clinical PracticeHIPAAFQHC-Based ResearchCommunity-Based ResearchSponsor Monitoring Visits

About the role

Key responsibilities & impact

Manage and maintain regulatory documentation and compliance requirements for clinical research studies, clinical trials, and human subjects research projects
Support study start-up, including protocol and sponsor-material review, feasibility, start-up checklists, document collection, and study readiness
Prepare, coordinate, submit, and track IRB applications, amendments, continuing reviews, reportable events, and study closures
Maintain current IRB approvals, consent forms, recruitment materials, protocol documents, and version-controlled participant-facing materials
Develop and maintain regulatory binders or electronic regulatory files
Maintain complete, accurate, and inspection-ready essential regulatory files
Support internal quality checks, sponsor monitoring visits, IRB audits, FDA inspections, and internal compliance reviews
Assist with monitor findings, audit observations, corrective action requests, protocol deviations, noncompliance issues, reportable events, and regulatory follow-up
Track research staff training, delegation of authority logs, certifications, licenses, and onboarding requirements
Assist with research regulatory SOPs, templates, trackers, and workflows
Communicate regulatory requirements and serve as 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 compliance, research integrity, and participant protection

Requirements

What you’ll need

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
Experience in clinical trials, academic research, FQHC-based research, or community-based research preferred
Familiarity with FDA regulations, Good Clinical Practice, HIPAA, and institutional review board requirements
Experience with electronic regulatory platforms or IRB systems preferred
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
Ability to uphold ethical research standards, protect research participants, and follow applicable policies and regulations
Ability to work respectfully with diverse communities, patients, staff, investigators, and external partners
Ability to maintain accurate documentation and timely communication

Benefits

Comp & perks

Some local travel, evening hours, or flexible scheduling may be required depending on study needs
Training, team meetings, quality improvement activities, and performance review processes
Equal opportunity employment