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The Principal Investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes.
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The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs. The Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
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Required Licenses and Certifications Registered Nurse (RN) in the State of Ohio Required and Certification in Human Subjects Protection (CITI) Protection, Good Clinical Practices, HIPAA, and CITI Training Required and Basic Life Support (BLS) Required and OH Driver's License (Valid) with car insurance coverage.
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Have working knowledge of ICH-GCP, US CFR, and HIPAA regulations. The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical trials under the direction of the Director/Manager of Clinical Site Operations and the Principal Investigator.
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Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), Institutional Review Board (IRB), HIPAA regulations and institutional requirements, which includes, but not limited to, the following duties: Knowledge of all regulatory requirements and institutional requirements when conducting the study protocol(s.
$30.55 - $44.3 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Be responsible for departmental facets of HIPAA, GLP, GCP, clinical data integrity and security, and code of ethics. Sufficient understanding of FDA regulations and international regulatory requirements, clinical research methods, and biostatistics, as relevant to medical products.
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Our client is looking for a US board certified General Medicine Physician, Principal Investigator who will conduct and coordinate the daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes.
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Awareness and understanding of HIPAA, GCP and clinical research regulations as they apply to healthcare informatics, preferred. Regular activities include, but are not limited to, the following: monitoring of clinical research software; troubleshooting and reporting software issues; supporting end-users; supporting software upgrades, managing configuration of software; assisting with implementation of new processes; organizing and maintaining the electronic Trial Master File (eTMF); and liaising with Digital Products and Services (DPS) to support clinical research conduct in information systems.
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This includes study implementation, recruitment of participants, conduct of study assessments, and documentation according to standards of good clinical practices (GCP), US Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards, (IRB) and institutional policies and procedures.
$27.5 - $44 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, HIPAA and company standard operating procedures and policies.
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Ensures adherence to applicable rules and guidelines of governing bodies such as FDA, HHS OHRP, TJC, HIPAA, CFR and GCP. Follows the Principles of Good Clinical Practice (GCP) in the oversight of clinical research activities at SVMHS.
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Under the supervision of the Clinical Research Program Manager, the Clinical Research RN ensures the integrity and quality of clinical trials are conducted and maintained in accordance with federal, state, and local regulations, Institutional Review Board ("IRB") approvals, and Salinas Valley Memorial Healthcare System ("SVMHS") policies and procedures.
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Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes.
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Essential Job Duties: Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP /regulatory compliance Evaluates and assesses participants to ensure only eligible participants enroll into the trials.
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Ensures compliance with Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP), Institutional Review Boards (IRB), Health Insurance Portability and Accountability Act (HIPAA), University of Colorado Hospital (UCH), University of Colorado Denver (UCD) and other pertinent regulatory agencies.
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