Research Regulatory Coordinator

Jobtailor; Moorestown Township (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Virtua is seeking a Regulatory Affairs Coordinator to support regulatory activities for phase II–IV clinical trials. You will prepare IRB applications, maintain study documentation, and coordinate with local, external, and central IRBs to ensure timely submissions.

The role involves keeping investigators and study teams informed, managing databases, and preparing reports. Strong organization and communication skills are essential.

Qualifications

• Minimum of 3 years supporting regulatory activities in clinical research.
• Experience preparing IRB applications.
• Experience preparing investigator documentation.
• Experience coordinating the protocol approval process.
• Mandatory education on Human Subject and Good Clinical Practice education.

Responsibilities

• 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
• 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

Skills

Strong organizational skills

Excellent communication skills

Interpersonal skills

Independent functioning

Education

Associate degree

Bachelor’s degree preferred

Tools

Virtua Website Management

Job description

• 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

• 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

Core Competencies

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 Coordination
• IRB Application Preparation
• Clinical Trial Documentation Management
• Good Clinical Practice Education
• Financial Tracking and Auditing

ATS Optimization Keywords

Hard Skills

• Regulatory Document Preparation
• Protocol Approval Coordination
• Clinical Trial Implementation
• Quality Audit Participation
• Database Development and Maintenance

Soft Skills

• Strong Organizational Skills
• Excellent Communication Skills
• Interpersonal Skills
• Independent Functioning

Certifications & Qualifications

• Associate Degree
• Bachelor’s Degree Preferred
• Human Subject Education

Industry Keywords

• Clinical Trials
• IRB
• Regulatory Compliance
• Clinical Research Best Practices

Tools & Technologies

• Virtua Website Management