Clinical Research Regulatory Coordinator 2

Inova Cancer Research Center is looking for a dedicatedClinical 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:offeringup to $5250 per year in education assistance and up to $10000 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 2Responsibilities:

• 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.