Clinical Research Regulatory Coordinator 1
Overview
The Clinical Research Regulatory Coordinator 1 leads regulatory document collection and sponsor communication while ensuring regulatory integrity across trials from approval to closure. This role supports the study process and maintains compliance throughout the trial lifecycle.
What You'll Do9
- 1Explains 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
- 2Demonstrates subject protection under direct supervision
- 3Explains the investigational products development process and identifies key regulations to control these processes
- 4Performs study regulatory activities in compliance with Good Clinical Practice GCP, federal regulations, and Inova policies
- 5Coordinates the preparation and submission of new studies to appropriate committees including the Office of Research at Inova, DSMC, PRMC, IRBs, and other committees
- 6Coordinates the start-up activities of multiple studies including IRB, contract, and budget submissions
- 7Submits regulatory documents to support initial reviews, continuing reviews, and amendments
- 8Responds to questions, generates reports, and maintains research files and documentation involving regulatory requirements for the study/clinical trial
- 9May perform other duties as assigned
Requirements3
- 1Associate’s Degree
- 22 years of regulatory coordination experience preferred
- 3Certification through SOCRA or ACRP preferred
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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