Title: Regulatory Affairs Assistant

Location: Choose an item.

Job Description:

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.

The Regulatory Affairs Assistant supports efforts to ensure regulatory submission targets are met. Completes all duties under the direction of the Regulatory Manager or Site Director. In executing these position responsibilities, the Regulatory 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:

Administrative:

• Has a general understanding of GCP/ICH guidelines
• Assists with collecting and preparing regulatory documents for submission to sponsor and IRB
• Assists with maintaining current regulatory-related documents to include CVs, licenses, and required training documents
• Assists with set-up of electronic Investigator Site File for all awarded studies
• Collects signatures on regulatory documents as required
• Assists with maintaining current study logs such as Screening and Enrollment Logs, Training Logs
• Assists with filing study-related correspondence (sponsor, IRB, etc) in the Investigator Site File.
• Assists with resolution to regulatory items identified during monitoring visits.
• Maintains current training with applicable SOPs/WIs, GCP, etc.
• Assists with archiving of study documents following study closure.
• Performs all other duties as properly assigned

Skills and Qualifications:

• Education and experience
  • High School Diploma or its equivalent; Two year degree preferred
  • Clinical Research experience preferred but not required
• Requirements
  • Working knowledge of medical terminology and the clinical research process
  • Attention to detail
  • Organizational Skills
  • Strong computer skills, including knowledge of all components of Microsoft Office are required