Clinical Research Regulatory Coordinator 1

Inova • Falls Church, VA

12h • $63,336 - $103,238 • Onsite

About The Position

Inova OBGYN Research is looking for a dedicated Clinical Research Regulatory Coordinator 1 to join the Team. This full-time role will be day-shift working Monday - Friday located in Falls Church, VA. The Clinical Research Regulatory Coordinator 1 (CRRC) supports the study process and is responsible for collecting and providing sponsors with regulatory documents. Responsible for clinical studies through the regulatory portion of the trial; maintaining the regulatory integrity of assigned studies from approval to closure.

Requirements

• Associate’s Degree

Nice To Haves

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

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 identify 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.

Benefits

• medical, dental and vision coverage
• robust team member wellness program
• Inova matches the first 5% of eligible contributions
• up to $5,250 per year in education assistance
• up to $10,000 for student loans
• 25 mental health coaching or therapy sessions, per person, per year, at no cost.
• paid time off
• paid parental leave
• flexible work schedules

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree