Clinical Research Regulatory Coordinator 2

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. #J-18808-Ljbffr Inova Health System