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Assist the Lab Manager to guarantee compliance with local, state and federal accrediting and regulatory organizations regarding all processes and patient sample testing including compliance with OSHA, FDA, NYSDOH, Joint Commission, CLIA etc.
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POSITION SUMMARY Reporting to the Microbiology Supervisor, the microbiology Clinical Laboratory Scientist is a Licensed Medical Technologist whose primary responsibility is to perform laboratory testing on patient’s samples within the Microbiology section of the laboratory.
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Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration. Quantitative Dimensions:The Analyst II, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements.
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Partner with R&D partners to deliver analytical data pipeline with a focus on oncology biomarker, diagnostic, and sample management. Provides key sophisticated analytical support for clinical programs with a precision medicine focus.
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The Analyst II, QC will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to ddPCR, nucleic acid purification/detection, protein quantification, ELISA, and gel electrophoresis.
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Draft/revise SOPs and work instructions for sample management activities. Support sample management for routine in-process testing. Provide training to team members on sample and inventory management systems.
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Experience in study management, clinical-ops, human biological sample management and related process development. You will establish and manage standards and processes for main study operations activities (e.g., clinical trial support, clinops human biological sample management.
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Work with Sample Administration Supervisor regarding sample storage, return, and disposal as well as other related sample management functions. QPS’ Story:Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services.
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Responsible for sample management, test performance, quality control, result review, result reporting and equipment maintenance such that accurate and appropriate sample testing is performed, completed, and reported in a timely manner.
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Works closely with Director, Sample Management and Lab Support, and Central Lab leadership to ensure employee engagement, department alignment and agility, and to establish and improve processes.
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Support the Client Biologic Sample Management Team in matters related to regulatory compliance including informed consent. Understand the use and application of bioanalytical and biomarker assays in clinical trials.
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Work Preformed Operations, Study and Site Management – 15% Effort The CRS Sr will ensure proper sample collection and handling requirements for each clinical trial overseen in the lab according to established Standard Operating Procedures (SOPs), Duke, IRB, and GCP standards.
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The Sample Management Coordinator will ensure tasks performed are conducted within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs.
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Responsible for performing testing in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Takeda and BioLife policies, procedures and quality initiatives.
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