Research Regulatory Coordinator

Lourdes Health System

Research Regulatory Coordinator coordinating IRB compliance and regulatory documentation for phase II–IV clinical trials. Supporting Virtua Health’s South Jersey healthcare services and clinical research program.

Posted 8/20/2026full-timeMoorestown • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $26 - $39 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory activities for clinical trials, including IRB applications, protocol approval processes, and compliance with Good Clinical Practice. Strong organizational and communication skills are essential for managing documentation and coordinating with study teams and investigators.

Highest-signal resume keywords

Regulatory Activities CoordinationIRB Application PreparationClinical Trial Documentation ManagementGood Clinical Practice EducationFinancial Tracking and Auditing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationProtocol Approval CoordinationClinical Trial ImplementationQuality Audit ParticipationDatabase Development and Maintenance

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsIndependent Functioning

Tools & Technologies

Virtua Website Management

Certifications & Qualifications

Associate DegreeBachelor’s Degree PreferredHuman Subject Education

Industry Keywords

Clinical TrialsIRBRegulatory ComplianceClinical Research Best Practices

About the role

Key responsibilities & impact

Coordinate regulatory activities for participation in phase II–IV clinical trials
Prepare and submit IRB regulatory documents and correspondence, including new and renewal applications, amendments, continuing reviews, reportable events, consent forms, protocol deviations, and adverse event reports
Work with local, external, and central IRBs and research review committees to complete and file required documents accurately and timely
Keep principal investigators, sub-investigators, and study teams informed about regulatory operations and activation processes
Manage and organize regulatory study documentation and files according to sponsor, regulatory, and internal requirements
Develop regulatory standard operating procedures aligned with clinical research best practices
Prepare regulatory documents for audits and monitoring visits and participate in quality audits
Support clinical trial implementation, close-out, follow-up, and communication among study sites, investigators, clinical research teams, and IRBs
Ensure investigators and study teams complete required regulatory training
Attend study team meetings, sponsor meetings, and in-service education
Track clinical trial finances, invoice sponsors, track payments, and conduct internal financial audits
Maintain the protocol directory and update the Virtua website with clinical trial information
Develop and maintain databases and prepare regular and ad hoc reports and forms
Order clinical research and office supplies and perform miscellaneous administrative activities

Requirements

What you’ll need

Minimum of 3 years supporting regulatory activities in clinical research
Experience preparing IRB applications
Experience preparing investigator documentation
Experience coordinating the protocol approval process
Able to function independently
Strong organizational skills
Excellent communication and interpersonal skills
Associate degree required; Bachelor’s preferred
Mandatory education on Human Subject and Good Clinical Practice education

Benefits

Comp & perks

Medical/prescription insurance
Dental insurance
Vision insurance
Health and dependent care flexible spending accounts
403(b) (401(k) subject to collective bargaining agreement)
Paid time off
Paid sick leave as provided under state and local paid sick leave laws
Short-term disability
Optional long-term disability
Colleague and dependent life insurance
Supplemental life and AD&D insurance
Tuition assistance
Employee assistance program including free counseling sessions