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Manage aspects of the study related to ratings with the rater training representative, study sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements. In executing these responsibilities, the Rater is guided by FDA regulations, Good Clinical Practice (GCP), relevant workplace practices, and company standard operating procedures.
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Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
$73,780 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Facilitates all audits of study with staff of JFK Medical Center, sponsor, FDA, and other regulatory agencies. Mandatory education on human subject research and GCP (CITI Training and Certification.
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Three years of QA or five years of GxP regulated (GLP, GMP, GCP) industry experience; Provide clarity to the Quality Management System (QMS) during sponsor audits and other external audits.
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In this role, you will be responsible for preparation, submission and maintenance of regulatory applications to fulfill research requirements for open studies in addition to working with Sponsor monitors to timely process, review and collect regulatory documents maintained in the Investigator Site File. All work should be completed according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) and government regulations.
$24.28 an hourFull-timeExpandUpdated 9 days ago - UpvoteDownvoteShare Job
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Discounts on local sports games, local fitness gyms and attractions Official Sponsor of FC Cincinnati. Understanding of GCP, GMP, GxP is preferred. As a member of the project study team, attend internal, Sponsor, and/or Vendor teleconferences; and.
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The ideal candidate will possess:Knowledge and interpretation of GCP regulations and standards, with understanding of phase appropriate application of GCP expectations. Direct experience with FDA and/or EMA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s.
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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate.
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Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
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Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
$111,972 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Program Director demonstrates expert clinical, organizational, and communication skills and functions as a resource regarding the clinical research and/or grants process, and demonstrates expert understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, ICH, GCP, OHRP, IRB, NIH.
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The Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study. Identify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirements.
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Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
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Site Manager The Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.
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Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
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