Clinical Research Regulatory Coordinator 1

About the role

This full-time day-shift role is located in Fairfax, VA, Monday–Friday. The Clinical Research Regulatory Coordinator 1 supports the study process by collecting and providing sponsors with regulatory documents, maintaining the regulatory integrity of assigned studies from approval to closure.

Responsibilities

• Explains basic elements of subject safety, including the role of an Institutional Review Board/Independent Ethics Committee, study documentation requirements, and event reporting.
• Demonstrates subject protection under direct supervision.
• Explains the investigational product development process and identifies key regulations governing these processes.
• Performs study regulatory activities in compliance with Good Clinical Practice (GCP), federal regulations, and Inova policies.
• Coordinates preparation and submission of new studies to appropriate committees (e.g., Office of Research at Inova, DSMC, PRMC, IRBs), including drafting and/or editing informed consent documents.
• Coordinates start-up activities for multiple studies, including IRB, contract, and budget submissions.
• Submits regulatory documents to support initial reviews, continuing reviews, and amendments.
• Responds to questions, generates reports, and maintains research files and documentation involving regulatory requirements.

Minimum Qualifications

• Associate’s degree or relevant experience in lieu of degree.

Preferred Qualifications

• 2 years of regulatory coordination experience.
• Experience with site-based clinical research.
• Certification through SOCRA or ACRP.

About Us

Inova is Northern Virginia’s leading nonprofit healthcare provider, with 26,000+ team members delivering world-class healthcare daily. We are consistently ranked a national leader in safety, quality, and patient experience, and we support our people through best-in-class facilities and professional development opportunities.

Benefits

• Health: Medical, dental, and vision coverage plus a robust wellness program.
• Retirement: Inova matches the first 5% of eligible contributions starting on your first day.
• Tuition and Student Loan Assistance: Up to $5,250 per year in education assistance and up to $10,000 for student loans.
• Mental Health Support: Up to 25 free mental health coaching or therapy sessions per person per year for team members, their spouses/partners, and their children.
• Work/Life Balance: Paid time off, paid parental leave, and flexible work schedules.