Quality Control Specialist

Company: Evolution Research Group
Location: Rochester
Posted on: January 15, 2021

Job Description:

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. ERG has 240+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, 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 ERG portfolio consists of Richmond Behavioral Associates, Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Finger Lakes Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center and Endeavor Clinical Trials all supported by an industry leading centralized infrastructure located in New Jersey.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. We accomplish this with employees who are passionate about clinical research, focused on patient care and respect and use excellence as their yardstick in everything they do each day.Position Summary: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.Essential Duties and Responsibilities:* Has working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOP's and individual protocols* Perform Quality Control to maintain audit and inspection readiness of studies* Ensures all study related communication is documented and identified any areas that need further clarification or inconsistencies to the Site Director* Works with site staff, vendors, and contract employees to obtain quality data* Review Source Documents, CRF's, Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness and accuracy* Issues queries as applicable for all reviewed documentation and trends queries for systemic issues. Reports feedback to Vice President, Quality Assurance* Reviews monitor follow-up letters and ensure outstanding issues are resolved* Meet with sponsors, monitors, and auditors during their visits and document close out minutes as applicable for the Quality Team* Evaluate audit findings and oversee implementation and effectiveness or appropriate corrective actions under the guidance of Quality Assurance* Perform QC functions as directed by the Vice President of Quality Assurance in collaboration with Site Director input* May assist with developing new Work Practices as they relate to Quality* Comply with the confidentiality of research data* Study, learn, and comply with ERG site standard operating procedures and other policies practices and regulations where applicable* Maintain current training with SOP, WPs, CITI, GCP, and HIPAA* Process a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and a general understanding of all active study protocols* Attend meetings, study initiation visits, and all other study-related visits by monitors or sponsor representatives* Performs other duties as assigned* Always represents research site in a professional manner when interacting with sponsors, volunteers, outside vendors, and fellow employeesQualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.The ideal candidate will have:* 2 year degree in a related field and a minimum of 2 years of experience conducting or managing clinical pharmaceutical/ device research studies or experience in the clinical research industryKnowledge, Skills and Abilities:* 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.* Excellent verbal and written communication skills

Keywords: Evolution Research Group, Rochester , Quality Control Specialist, Other , Rochester, New York