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RESEARCH COMPLIANCE: Performs quality assurance checks in accordance with department SOPs to ensure protocol compliance, Good Clinical Practice (GCP) and all other applicable regulatory requirements.
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Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
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The legal services portion of duties will be to provide legal advice and counsel to Moffitt management and staff regarding bio-medical focused research, intellectual property, grants, ethics and regulatory compliance, and related contracting.
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As the Director of Regulatory Compliance (MLRO), you will be working as part of Nium's global, dynamic Compliance team and will be reporting to the VP Compliance (US). Identify control gaps and lead the implementation of control enhancements to include AML, OFAC, and Regulatory Compliance.
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Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements.
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Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines. " Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
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The Clinical Lab Assistant reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
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The Clinical Research Nurse I serves as Clinical Research Nurse 1 for phase I, II and III oncology clinical trials conducted in the Lombardi Clinical Trials Office (Lombardi CTO) at Lombardi Comprehensive Cancer Center.
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One year of clinical nursing experience One year of clinical research experience is preferred One year of experience treating oncology patients is preferred About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials.
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The Resource Nurse provides guidance and education on the hospital's standard of nursing practice, policies, and procedures to ensure compliance with all accrediting and regulatory agency requirements.
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They also work closely with Lombardi Clinical Trials Office team members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory and Tissue Technicians.
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Support policy development and contract compliance for Relativity's federal programs and develop and deliver training on various regulatory and compliance topics for Company employees, with special emphasis on global trade compliance, customer and vendor due diligence and government contracting obligations.
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The CCO will work closely with senior leadership to mitigate risks, maintain regulatory compliance, and foster a culture of integrity and accountability. The CCO will be responsible for developing, overseeing and managing all aspects of regulatory compliance within Lightspark.
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clinical trials regulatory compliance jobs Title: investigator
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