Clinical Research Regulatory Coordinator 1

Inova Fairfax Research Center - OBGYN team is seeking a dedicated Clinical Research Regulatory Coordinator 1 to join the team. This role will be full-time day shift from Monday - Friday, Day shift.

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, and remote and hybrid career opportunities.

Clinical Research Regulatory Coordinator 1 Job Responsibilities:

• Explains the investigational products development process and identify key regulations to control these processes.
• 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.
• 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.
• Submits regulatory documents to support initial reviews of studies, continuing reviews, and amendments.

Clinical Research Regulatory Coordinator 1 Additional Requirements:

• Work schedule: 8-hour shift (Monday - Friday, Days.)
• Education: Bachelors Degree preferred. Associates degree required.
• Experience: One (1) year clinical research experience or Two (2) years clinical experience with Associate degree.

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