ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS.? With 12 wholly owned clinical sites and 12 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.
ERG is looking to hire multiple clinical research Quality professionals across the organization nationwide. Please indicate on top of your resume which position and location you are interested in.
The current positions we have open are:
Director QA – Miami, FL The role of the Director of Quality Assurance is to ensure that all clinical trials are conducted in accordance with study protocols, FDA regulations, and ICH/GCP guidelines by way of internal audits, FDA Inspections, Sponsor audits, vendor audits, oversight of training, quality control, and the maintenance of all Quality driven activities at the clinic. This position is also part of the Quality Mobile Unit (QMU) which may require assistance and support of the overall Quality Management System for ERG to promote quality assurance, quality control, compliance, and auditing activities as they relate to conduct of studies or vendor management for all portfolio clinics.
Highlighted requirements include: Thorough understanding of Good Clinical Practices (GCP), FDA Regulations and Guidelines as they apply to clinical research; Bachelor’s degree preferred, or equivalent in experience; 10 or more years relevant experience in clinical research with a strong emphasis in Quality Assurance; at least 5 years’ experience participating in inspections by the United States Food and Drug Administration, or other compliance agencies preferred.
QC Specialist– Miami, FL; Rogers, AR; Staten Island, NY; Rochester, NY The Quality Control Specialist will be responsible for the oversight of clinical research operations through inspecting and evaluating processes, procedures, and adherence to applicable regulations and guidelines. The QC Specialist will review data, identify trends, and communicates all incidents as they relate to clinical research to the Vice President of Quality Assurance. This role is essential in helping train teams to reduce quality related problems and increase understanding of our culture of quality.
Highlighted requirements include: 4 year degree in a related field and a minimum of 1 year of experience conducting or managing clinical pharmaceutical/ device research studies or experience in the clinical research industry; Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
Superior knowledge of multiple operational functions and principles, including quality assurance, finance, and employee management.
Proven ability to plan and manage operational process for maximum efficiency and productivity.
Ability to streamline and implement new structures and roles that create speed, efficiency, and support rapidly shifting business demands.
Strong working knowledge of industry regulations and legislative guidelines
Internal Number: Q22
About Evolution Research Group
ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors speed life-saving and life-enhancing therapeutics to market as quickly and safely as possible.
We conduct both inpatient and outpatient Phase I-IV clinical research studies. Our robust network of owned and affiliated clinical research sites includes a Phase I clinical pharmacology unit, several early-phase specialty units, a purpose-built research facility specializing in acute pain with two dedicated operating rooms, and two postoperative surgical analgesic facilities. Our centers have sophisticated pharmacy capabilities, including infusion and formulation; on-site testing capabilities such as polysomnography (PSG), quantitative electroencephalography (qEEGs) and EEGs, FibroScans®, cerebrospinal fluid (CSF) sampling; and off-site supplemental services from medical imaging to ophthalmology through collaborative agreements.