Quality Control Specialist

Company: Evolution Research Group
Location: Staten Island
Posted on: January 27, 2023

Job Description:

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.All Quality Control Specialists will be responsible in supporting the success of Operations. Duties will include the evaluation of processes and their adherence, as well as the inclusion of applicable regulations and guidelines. Data reviews will be completed to ensure that the Operations team is consistent in their documentation and their review of the data they collect so that meaningful information such as trends may be communicated up to Quality Assurance and Operational Leadership for process improvements and risk mitigation efforts.Quality Control Specialist Responsibilities:Working knowledge of clinical research FDA regulations, GCP/ICH guidelines, clinic SOPs and Work Instructions, and protocolsManages Quality Control as directed by a Quality Plan in all aspects as defined by the plan.Routinely reviews clinical research data for completeness and accuracy but also for trends or other areas of risk that may impact quality.Brings findings (by way of data reviews or observations on the floor) to Site Director or Quality Assurance leadership to determine next steps.Responsible to assist QC team in tracking items to completion such as open incidents, CAPAs, Audit responses, or other items as assigned.Assist and support the Quality team where applicable for audits, inspections, or other activities as determined.Comply with confidentiality of research data and protecting study participants Health Information where applicable.Maintain current training with applicable SOPs/WIs, GCP, HIPAA, etc.Keep notes/minutes from team meetings to assist with the facilitation of actions or tracking of items for the team.Assist and support training efforts executed by the QC team or oversight on compliance as a result of Operational trainings.May assist in communications with sponsors/CROs or vendors where needed.May assist with the development of Quality relates procedure development or implementation of new systems.Possess 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.Skills and QualificationsEducation and Experience2-year degree in a life science field or equivalent experience/exposureExperience in a highly regulated environment required, at least 2 years of experience in Clinical Research or Pharmaceuticals preferredRequirementsCommunicate with others in a collaborative and courteous mannerEffectively communicate issues to all levels within the organizationBasic computer skills including the use of different applications such as Word or ExcelExperience with using electronic systems such as CTMS, eQMS, eSOURCE desirable

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