Clinical Research Regulatory Coordinator 2

Inova Cancer Research Center is looking for a dedicated Clinical Research Regulatory Coordinator 2 to join the Team. This full-time role will be day-shift working Monday - Friday located in Fairfax, VA.

The Clinical Research Regulatory Coordinator 2 (CRRC) plays a significant role in supporting 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; maintains 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: 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.

Clinical Research Regulatory Coordinator 2 Responsibilities:

• Ensures subject safety, related documentation and reporting. Recognizes situations requiring escalation and minimizes risks.
• Executes GCP-related regulatory clinical study activities.
• Coordinates the preparation and submission of new studies to appropriate committees, 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: Bachelors Degree or experience equivalent to education
• Certification: Research certification upon hire. Must apply for certification after 2 years of clinical research experience (e.g. CCRC, ACRP-CP, CCRP, etc.)

Preferred Qualifications:

• 2 years of regulatory coordination experience preferred.

• Experience with site-based clinical research preferred.

• Previous experience working as a Clinical Research Regulatory Coordinator.