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Provide advise regarding informed consent, privacy, clinical trials, and employment matters. Advising on federal and state health care laws and regulations such as Anti-Kickback statute, Stark Law, False Claims Act, HIPAA, fraud and abuse laws, the Affordable Care Act, and Medicare related regulations.
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This position will support the VP, Therapeutic Area Lead in successful execution of clinical trials including engaging appropriately in scientific exchanges around product information, disease education, and research ideas/activities with KOLS, investigators, physicians, and ancillary HCPs regarding current and future therapies in development.
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Assure that trials are in compliance with applicable FDA and ICH (International Conference on Harmonization) regulations, HIPAA, GCP (Good Clinical Practice) guidelines, SOPs (Standard Operating Procedures) and Quality System.
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Develop and maintain professional relationships to ensure timely, effective, and appropriate communication of current and emerging medical and scientific information on therapeutic disease areas in support of clinical trials.
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The Clinical Trial Nurse Manager (CTN-Manager) position assists in the administrative leadership and direction of the operational aspects of a large and/or multiple regional clinical trials program.
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Reporting to the Radiology CRG Clinical Research Manager, the Clinical Research Coordinator 2 – Radiology will be conversant in the goals, mission, and priorities of the Institute, and utilize this knowledge to oversee complex clinical research trials.
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Ability to make sound decisions under stressful situationsStrong digital literacy and organizational skills and attention to detailWorks well independently or in a team, in a fast paced, multi-tasking environment and maintains production and quality standardsMust be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety ManualBasic knowledge of clinical trial processes, patient confidentiality (HIPAA) and ICH-GCP guidelines.
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Prior IRB experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. As part of its strategic plan, our researchers and scientists have been responsible for ground-breaking advancements in areas across the scientific spectrum, including: Cancer Biology, Cardiovascular and Thrombosis, Cell and Developmental Biology, Clinical Lung Research, HIV, Immunology and Autoimmunity, Metabolic Syndrome and Diabetes, Neuroscience, Substance Abuse, Translational Medicine and more.
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Collaborates with PI and Sponsor in establishing, implementing, and conducting clinical trials. Assist in development of clinical trials technology systems and infrastructure.
$168,100 - $217,470 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development. Minimum of five years of experience related to the management and conduct of clinical trials in an academic setting.
$41.92 - $64.97 an hourFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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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Experience with conduct of clinical research with pharmaceutical/device clinical trials and/or observational or social behavioral and/or public health research. 5 - 8 years relevant experience working as a clinical research coordinator role (project manager, research assistant, study coordinator, etc.
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The Neurology Clinical Trials Organization (NeCTO) is seeking an experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team.
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CITI Program Certificate in the following courses: (a) Biomedical (Human Subjects Research); (b) Conflicts of Interest; (c) Good Clinical Practice for Medical Research, and Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus.
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Functionalizes the details of research protocols and clinical trials by analyzing the type of tissue needed and ensuring the integrity of the tissue (10%) In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy.
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