Clinical Research Regulatory Coordinator 1

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.

Inova is consistently ranked a national healthcare leader in safety, quality and patient experience. We are also proud to be consistently recognized as a top employer in both the D.C. metro area and the nation.

Featured Benefits:

• Committed to Team Member Health: offering medical, dental and vision coverage, and 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: offering up to $5,250 per year in education assistance and up to $10,000 for student loans. 
• Mental Health Support: offering all Inova team members, their spouses/partners, and their children 25 mental health coaching or therapy sessions, per person, per year, at no cost. 
• Work/Life Balance: offering paid time off, paid parental leave, flexible work schedules. 

Clinical Research Regulatory Coordinator 1 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.

Minimum Qualifications:

• Education: Associate’s Degree

Preferred Qualifications:

• 2 years of regulatory coordination experience preferred.

• Certification through SOCRA or ACRP preferred.