Clinical Research Regulatory Coordinator 1

Inova Cancer Research Center is looking for a dedicatedClinical Research Regulatory Coordinator 1 to join the Team. This full-time role will be day-shift working Monday Friday located in Fairfax 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:offeringup to $5250 per year in education assistance and up to $10000 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:offeringpaid time off paid parental leave flexible work schedules.

Clinical Research Regulatory Coordinator 1Responsibilities:

• 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:Associates Degree (or relevant experience in lieu of degree)

Preferred Qualifications:

• 2 years of regulatory coordination experience preferred.

• Experience with site-based clinical research preferred.

• Certification through SOCRA or ACRP preferred.