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Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines.
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Assist in the planning, implementation, and management of clinical trials to ensure they are conducted in accordance with the FDA, IND, NDA, ICH, and GCP guidelines. Comprehensive knowledge of FDA, IND, NDA, ICH, GCP regulations, and guidelines.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Demonstrates expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, GCP, OHRP, IRB, NIH/NCRR.
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Administration (FDA) and its agencies, Department of Defense, and Defense Health Agency (DHA). Administration (FDA) and its agencies, Department of Defense, and Defense Health Agency (DHA). Perform, maintain, and document Disaster Recovery Procedures, e.g., maintain system disc integrity, perform backups and fail-over tests, monitor system performance, and conduct capacity planning and general troubleshooting.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies.
$21.65 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications.
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Previous experience in FDA regulated biotechnology or pharmaceutical environment is strongly preferred. Under supervision, the Production Lab Tech - Mfg Histology performs laboratory activities in the manufacturing lab including slide manufacturing events and packaging events and assists in tasks required for block qualification; follows the manufacturing schedule to complete required tasks per standard operating procedures involving basic laboratory techniques, calculations, material measurements, operation of laboratory equipment and record keeping as necessary.
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The Mfg Lab Technician performs laboratory activities in the manufacturing lab including Buffer and antibody manufacturing. AA/AS/BA/BS degree in biological science or biochemistry field OR. Facilitate in the development of documents, and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and ISO compliance, and increase efficiency.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Skills: Quality control, SOP, FDA, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice) Minimum two (2) years of experience in an FDA/ISO or other regulated environment is preferred.
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Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS. Experience 2-5 Years' experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse Coordinator and proven experience as an Lead Auditor.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Knowledge and familiarity of e-regulatory systems (Veeva), DocuSign, ImageNow and other applications used in the conduct of clinical research along with the relevant regulations. Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.
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To submit proof of full vaccination with one of the three COVID-19 vaccines approved and/or authorized by the FDA, or proof of having received the first vaccine dose with the second dose scheduled, on or before their first day of employment, unless the associate has been approved for an exemption.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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A working knowledge of FDA, DHHS, IRB and other agency guidelines that govern clinical research. Support regularly document development, including editing Sponsor documents to match OHSU requirements, as part of study start-up.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information.
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