Clinical Research Regulatory Coordinator 1 at Inova

Fairfax, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

0.0

Posted On

15 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Clinical Research, Good Clinical Practice, Institutional Review Board, Ethics Committee, Informed Consent Documents, Regulatory Submissions, Document Preparation, Event Reporting, Subject Safety

Industry

Hospitals and Health Care

Description

Inova Research Center – Cancer team is seeking a dedicated Clinical Research Regulatory Coordinator 1 to join the team. This role will be full-time hybrid 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. Minimum Requirements: Education: Bachelor’s degree preferred. Associates degree required. Experience: One (1) year clinical research experience or Two (2) years clinical experience with Associate degree. Preferred Requirements: Experience working with research grants. Research and regulatory experience #LI-MF1 We are Inova, Northern Virginia’s leading nonprofit healthcare provider. Every day, our 26,000+ team members provide world-class healthcare to the communities we serve. Our people are the reason we're a national leader in healthcare safety, quality and patient experience. And from best-in-class facilities to professional development opportunities, we support them at every step. At Inova, we're constantly striving to be ever better — to shape a more compassionate future for healthcare. Inova Health System is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, pregnancy (including childbirth, pregnancy-related conditions and lactation), race, religion, sex, sexual orientation, veteran status, genetic information, or any other characteristics protected by law.

Responsibilities

This role involves explaining the investigational products development process and identifying key regulations, while also performing study regulatory activities in compliance with GCP and Inova policies. Responsibilities include coordinating submissions to various committees and drafting informed consent documents.