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