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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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Participate in sponsor investigator meetings whenever possible. Provide study reports as requested by the sponsor, IRB, and regulatory authority(ies) Work with the Site Director and Medical Director to provide oversight of Sub-Investigator.
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Communicate and collaborate with regulatory authorities and sponsors during regulatory inspections and sponsor audits. Piper Companies is actively seeking a Senior Quality Assurance (GCP) Specialist to join a global biopharmaceutical organization producing therapies for neruology and rare disease disorders.
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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.
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Identify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirements. Responsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessary.
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Completes data entry into case report forms ensuring accuracy of data and reporting of adverse events to sponsor; Ensures study related reports and patient results are reviewed by the Clinical Research Coordinator and/or Investigator in a timely manner; Organizes work area.
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Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. 10. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals 3.
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Triages, tracks and reports adverse events and deviations to the Investigator as well as the sponsor and IRB in accordance to their requirements. Workload including a majority of StrokeNet clinical trials as well as Industry Sponsored and Investigator Initiated.
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Certified Cryptocurrency Investigator - Blockchain Intelligence Group (CCI) The Candidate shall extract and fuse network, computer, and mobile data from multiple Sponsor data sources to provide value added technical analysis to inform operational planning.
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Electronic data capture (EDC) system (Medidata) and eTMF system (Florence). This position is part of the Clinical Affairs Department for the Clinical Decision Support business unit and is fully remote.
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Interact with the investigator, human subjects, Institutional Review Board, University, sponsor, and auditors to ensure smooth, accurate progress of clinical trials from planning stage through trial completion and poststudy closure.
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Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.
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Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
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