Title: Regulatory Affairs Coordinator

Location: RBA-Staten Island, NY

Job Description:

The Regulatory Affairs Coordinator is responsible for a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. The Regulatory Affairs Coordinator completes all duties under the direction of the Site Director. The Regulatory Affairs Coordinator is responsible for daily processing, correspondence and maintenance of master regulatory files and distribution of supporting documents. In executing these position responsibilities, the Regulatory Affairs Coordinator is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies

Responsibilities:

• Working knowledge of GCP/ICH guidelines as well as company SOPs
• Creates and maintains electronic Investigator Site File per FDA and sponsor requirements.
• Coordinates with site staff, vendors, and contract employees to obtain all related signatures, licensure, and necessary certifications required for regulatory compliance.
• Completes IRB submissions to include initial submission, revisions to research, promptly reportable items, and study termination reports to meet all required timelines.
• Tracks IRB submissions and approvals, study status and document expirations
• Maintains current study staff qualification documents in electronic repository, to include Curriculum Vitae reformatting and updates of investigator and sub-investigator supporting documents.
• Meets with sponsors, monitors, and auditors during their visits.
• Reviews and responds to monitor questions regarding regulatory documents and help to ensure that all regulatory issues identified are resolved at the time of the monitors’ visits.
• Maintains master list of all studies performed at site.
• Prepares Study Documents for Long Term Storage and maintains record retrieval information for all archived documents.
• Complies with the confidentiality of research data.

Skills and Qualifications:

• Education and experience
  • 1 year of clinical research experience is preferred.
  • High School Diploma or its equivalent; College degree preferred.
• Requirements
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Excellent communication skills (interpersonal, written, verbal)
  • Strong computer skills, including knowledge of all components of Microsoft Office are required.

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.