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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.
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Participates in clinical programs and coordinates the cQA interface with Contract Clinical Research Organizations (CROs), Contract Service Providers (CSPs), Bioanalytical Labs and Investigator Sites.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
$61,242 - $86,121 a yearExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
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2 years of clinical research coordinator experience strongly preferred. i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
$73,780 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The RN clinical research coordinator (CRC) is a clinical research professional working under the direction of their Novant Health leader and the principal investigator. Clinical Research Coordinator II Registered Nurse.
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Certified Clinical Research Professional or Society of Clinical Research Associates Certification or Certified Clinical Research Coordinator. The Research Nurse Coordinator is responsible for ensuring that the clinical research is conducted according to the research design including but not limited to screening and recruitment of patients, collecting and records of clinical data, maintaining regulatory binders and overall safety of human subjects.
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Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
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Understanding of Good Clinical Practice (GCP), 21 CFR Part 11 and other clinical research regulations/standards. Bachelors degree or higher in a technology, healthcare or clinical research related field or equivalent work experience.
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Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies. The Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities.
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May be responsible for education of clinic staff regarding clinical research. Experience working in clinical research is preferred. May collaborate with Research Site Leader in the study selection process.
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Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes. 3+ years minimum in clinical research or drug development.
$257,600 - $386,400 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Perform QC test and maintain log on products used for proceduresAssist research participants or other health care team members with prescribed interventions as directed by the Clinical Research Nurse.
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Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC.
$29.74 - $49.07 an hourFull-timeExpandApply NowActive JobUpdated 3 months ago
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