Clinical Research Regulatory Coordinator 1

About the role

Inova OBGYN Research is seeking a dedicated Clinical Research Regulatory Coordinator 1 to join the team. This full-time, day-shift position is located in Falls Church, VA, working Monday through Friday.

Responsibilities

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

Requirements

• Associate’s Degree (required).

Qualifications

• 2 years of regulatory coordination experience (preferred).
• Certification through SOCRA or ACRP (preferred).

Benefits

• Committed to Team Member Health: Medical, dental, and vision coverage, plus a robust team member 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: 25 mental health coaching or therapy sessions per person, per year, at no cost for team members, their spouses/partners, and their children.
• Work/Life Balance: Paid time off, paid parental leave, and flexible work schedules.

About Us

We are Inova, Northern Virginia’s leading nonprofit healthcare provider. Our 26,000+ team members deliver world-class healthcare to the communities we serve. We support our team with best-in-class facilities and professional development opportunities, shaping a more compassionate future for healthcare.