Job Title: Regulatory Affairs Coordinator

Location: San Antonio, Texas

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 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
• Create and maintain electronic Investigator Site File per FDA and sponsor requirements.
• Coordinate with site staff, vendors, and contract employees to obtain all related signatures, licensure, and necessary certifications required for regulatory compliance.
• Prepare and collect assigned study initiation documents and submit to sponsor/CRO in a timely fashion.
• Complete IRB submissions to include initial submission, revisions to research, promptly reportable items, and study termination reports to meet all required timelines.
• Track IRB submissions and approvals, study status and document expirations
• Maintain current study staff qualification documents in electronic repository, to include Curriculum Vitae reformatting and updates of investigator and sub-investigator supporting documents.
• Stay in constant communication with site staff regarding forthcoming IRB approvals to include protocols, consent forms, subject facing materials, and other related items.
• Meet with sponsors, monitors, and auditors during their visits!
• Review and respond to monitor questions regarding regulatory documents and help to ensure that all regulatory issues identified are resolved at the time of the monitors’ visits.
• Maintain master list of all studies performed at site.
• Prepare Study Documents for Long Term Storage and maintain record retrieval information for all archived documents.
• Maintain current training with applicable SOPs/WIs, GCP, etc.
• Comply with the confidentiality of research data.
• 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
  • 1 year of clinical research experience is preferred.
  • High School Diploma or its equivalent; College degree preferred.
• Requirements
  • Understand 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 organizational and interpersonal skills
  • Attention to detail.
  • Strong computer skills, including knowledge of all components of Microsoft Office are required.