Clinical Research Regulatory Specialist
Inova’s IHVI - Cardiology Research department is seeking a Full Time Clinical Research Regulatory Coordinator 1 to join their team.
The Clinical Research Regulatory Coordinator I (CRRC) plays a significant role in supporting a timely study start process and is responsible for collecting and providing sponsors with regulatory documents. Regulatory coordinators must have a working knowledge of institutional, federal and state policies. The position requires frequent interaction with Principal Investigators (PIs) and their research staff, as well as other Inova departments to ensure all regulatory documents and requirements are met and up to date. You will submit regulatory documents to support initial reviews of studies, continuing reviews, and amendments. The CRRC will respond to questions, generate reports, and maintain research files and documentation involving the regulatory requirements for the study/clinical trial. CRRCs are responsible for clinical studies through the regulatory portion of the trial; maintaining the regulatory integrity of assigned studies from approval to closure. The CRRC I works with other staff on regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries.
- Explain basic elements of subject safety including reasoning behind required use of an Institutional Review Board Independent Ethics Committee, study activity documentation, and event reporting requirements. Demonstrate subject protection under direct supervision.
- Explain the investigational products development process and identify key regulations to control these processes.
- Explain and perform study regulatory activities in compliance with Good Clinical Practice (GCP), federal regulations, and Inova policies.
- Explain institutional workflows and demonstrate an understanding of the processes required for study compliance.
- Explain the importance of professional conduct and describe leadership principles that impact the effective operation of an investigative site.
- Coordinate 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 document.
- Coordinates the start-up activities of multiple studies including IRB, contract, and budget submissions.
- Associates or higher OR experience equivalent to education (experience should include healthcare or research related employment