Clinical Research Regulatory Coordinator 1

Inova Health System; Fairfax (VA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical dental vision

Retirement match

Education assistance

Student loan help

Mental health support

Paid time off

Job summary

Inova Health System in Fairfax, VA, is seeking a Clinical Research Regulatory Coordinator 1 to support regulatory aspects of clinical studies. This full-time, day-shift role collaborates with the Inova Cancer Research Center to collect regulatory documents and maintain regulatory integrity from approval to closure.

The ideal candidate has an Associate’s Degree (or relevant experience) and is eager to learn in a fast-paced research environment.

Qualifications

• Associate’s Degree or relevant experience in lieu of degree.
• 2 years of regulatory coordination experience preferred.
• Experience with site-based clinical research preferred.
• Certification through SOCRA or ACRP preferred.

Responsibilities

• Explains basic elements of subject safety including IRB ethics, study activity documentation, and event reporting requirements under direct supervision.
• Explains investigational products development process and key regulations controlling these processes.
• Performs study regulatory activities in compliance with GCP, federal regulations, and Inova policies.
• Coordinates preparation and submission of new studies to appropriate committees, including drafting/editing informed consent documents.
• Coordinates start-up activities of multiple studies including IRB, contract, and budget submissions.
• Submits regulatory documents to support initial reviews, continuing reviews, and amendments.
• Responds to questions, generates reports, and maintains research files/documentation for regulatory requirements.
• May perform other duties as assigned.

Skills

Regulatory coordination

GCP

IRB submissions

Documentation

Regulatory compliance

Education

Associate’s Degree

Job description

Clinical Research Regulatory Coordinator 1

Job Description

Inova Cancer Research Center is looking for a dedicated Clinical 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 $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:offeringpaid time off, paid parental leave, flexible work schedules.

Clinical Research Regulatory Coordinator 1 Responsibilities:

• 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:Associate’s 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.

About Us

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 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.

Job Info

• Job Identification 688345
• Job Category Clinical Services
• Locations Inova Health Center 8081 - Fairfax East