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Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.
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The Senior Clinical 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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Experienced in coordinating project meetings, electronic medical records, protocol review revision, patient confidentiality, remote site monitoring, regulatory compliance, protocol development, clinical research, clinical trials, and protocol writing.
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This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned.
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Ensure the smooth running of the clinical research program team including that colleagues are updated on all relevant issues, develops systems to track multiple projects including all regulatory files, investigator and IRB information, patient recruitment activity and financial management as well as ensuring high data quality across all clinical trials.
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Clinical Research Medical Director, Rare Disease, US-Remote. Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
$256,334 - $318,868 a yearFull-timeRemoteExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 2 and/or 3 clinical trials.
Full-timeRemoteExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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2 years of clinical research experience and/or basic science research. + Identify new clinical research opportunities. + Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
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Interface with representatives from key functional groups (Monitoring, Data Management, Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, Legal, and European Clinical groups.
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Responsible for clinical trial Informed Consent and specimen collection as needed Serves as an ongoing resource for patient/caregiver education and support Communicates patient s progress/disposition to health care providers Aids in maintaining outcome database Aids in the management of IRB communications and regulatory updates Has a working knowledge and access to multiple electronic systems to facilitate patient care and documentation.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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4-6 years relevant work experience in positions involving research, policy analysis, consulting, or government initiatives relating to health policy; including part-time work or internships. We fund work across several broad issue areas: Provider Payment Incentives and Medicare Sustainability, Commercial Sector Prices, Drug Prices, Clinical Trials, and Complex Care. The team works with experts from inside and outside government - including industry and academia - to reform the health care system through evidence generation, policy development, communications, technical assistance, and advocacy to support systemic change, including through policy change.
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Find even more open roles in Ethical Hacking, Pen Testing, Security Engineering, Threat Research, Vulnerability Management, Cryptography, Digital Forensics and Cyber Security in general - ordered by popularity of job title or skills, toolset and products used - below.
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The Director must understand the entire preclinical and early clinical product development pipeline including product optimization, preclinical scale-up, and manufacture and toxicology, regulatory affairs, and early human clinical trials.
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Performs specialized laboratory research utilizing experimental protocols which involves specialized procedures to include ELISA assays, western blotting, and RT-PCR, as well as clinical assays of biochemical, coagulation and complete blood count readouts.
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MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization.
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clinical research regulatory jobs in Washington, DC
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