What are the responsibilities and job description for the Regulatory Specialist - Clinical Research position at SQRL?
HIGHLIGHTS
- Regional Regulatory Specialist opportunity supporting clinical research studies at a growing research site in the Charlotte, NC area
- Schedule: Monday–Thursday 7:30 AM–5 PM, with occasional Friday mornings
- Competitive pay of $24–$29/hour, depending on experience
- Comprehensive benefits including medical, dental, vision, 401(k) with 4% match, PTO, and paid holidays
- Work in a collaborative, mission-driven environment focused on research that improves lives
COMPANY
Our client is part of a rapidly expanding clinical research site network with 34 locations across 10 states. This organization is known for its entrepreneurial culture, strong leadership, and commitment to advancing clinical trials that improve patient outcomes. With continued growth planned through 2025 and beyond, employees have significant opportunities to develop their careers and take on new responsibilities as the organization expands.
POSITION
The Regional Regulatory Specialist supports clinical research studies by managing regulatory documentation and coordinating submissions to oversight bodies. This role partners closely with site leadership, investigators, and sponsors to ensure studies meet regulatory requirements and internal standards. The specialist maintains essential study documentation, prepares regulatory submissions, and supports inspections, monitoring visits, and audits. This position is ideal for someone who is organized, detail-oriented, and interested in growing within the clinical research field.
RESPONSIBILITIES
- Prepare and maintain regulatory binders and documentation for clinical research studies
- Coordinate regulatory submissions and updates to IRBs, sponsors, and other oversight agencies
- Track and maintain essential documents such as CVs, licenses, and training records
- Ensure regulatory files remain accurate, organized, and compliant with study protocols and federal regulations
- Support monitoring visits, audits, and regulatory reviews
- Maintain both electronic and paper regulatory records while protecting confidential patient and study information
QUALIFICATIONS
- High school diploma or equivalent required; associate or bachelor’s degree preferred
- 0–3 years of experience in clinical research, regulatory work, or a related healthcare field
- Strong organizational skills and attention to detail
- Ability to work independently while collaborating with cross-functional teams
- Proficiency with Microsoft Office and familiarity with research systems such as CTMS or electronic regulatory platforms preferred
- Strong written and verbal communication skills with a professional and ethical approach to work
Salary : $24 - $29