Regulatory Affairs Specialist jobs in Hialeah, FL

Title: Regulatory Affairs Assistant

Location: CPMI

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400 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.

Job Description:

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:

• General understanding of GCP/ICH guidelines
• Assist with collecting and preparing regulatory documents for submission to sponsor and IRB.
• Assist with maintaining current regulatory-related documents to include CVs, licenses, and required training documents.
• Assist with set-up of electronic Investigator Site File for all awarded studies.
• Collect signatures on regulatory documents as required.
• Assist with maintaining current study logs such as Screening and Enrollment Logs, Training Logs
• Assist with filing study-related correspondence (sponsor, IRB, etc.) in the Investigator Site File.
• Assist with resolution to regulatory items identified during monitoring visits.
• Maintain current training with applicable SOPs/WIs, GCP, etc.
• Assist with archiving of study documents following study closure.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

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.