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The Clinical Epidemiology Unit (CEU) of the Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), National Institutes of Health (NIH), is recruiting a talented individual to serve as Staff Scientist.
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The Lead Clinical Research Coordinator independently leads and oversees day-to-day operations of clinical research studies conducted by a principal investigator with minimal supervision.
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Proven experience in hematology/oncology drug development, designing and managing clinical trials (Ph 1b/II and Ph III) through investigator and regulatory interactions; experience with early-clinical development, including FIH and IND, is a plus.
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General Summary of Position Under the direction of the Principal Investigator (PI) and within the scope of nursing practice, the competent Clinical Research Nurse Coordinator I (CRNC I) with moderate supervision, assesses, plans and implements and evaluates the nursing care of potential research participants from pre-screening through study exit.
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Provide general insight into GSK research interests and field inquiries regarding investigator sponsored scientific or clinical research projects. Attend and contribute (if required) to medical portion of regional account planning/training sessionsAttend both national and regional scientific/medical meetings to gain medical voice of the customer on recent data being presented on products and disease states of interest to GSKSupport clinical development activities and programs including GSK and Investigator sponsored studies as well as collaborating with R&D staff to improve site performance.
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Assists the clinician/investigator in ensuring adequate source documentation and data-collection that validate the integrity of the clinical trial/research study. The CRNC I demonstrates professional accountability and responsibility for nursing practice, and coordinates care delivery with the principal investigator and other members of the clinical research teams and family.
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1+ year Life Sciences / Clinical Trials / Pharma / EDC experience; familiarity with the roles of a sponsor, CRA and Investigator; an EDC system; and ICH-GCP preferred but not required. About CRIO: CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture.
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Operates as part of a team of both nursing staff and research assistants who assist the study coordinator and Investigator in protocol implementation. Clinical Research Nurse, Clinical Research Unit - Georgetown University Medical Center.
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Create Project Needs Documents for newly identified clinical research projects, including Health Care Provider (HCP) nominations and Maximum FMV analyses for Investigator Initiated Research studies.
$110,000 - $120,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through appropriate internal processes.
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The Research Assistant 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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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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Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary.
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The Clinical Trial Navigator (CTN)II is a specialized research professional responsible for the coordination and administration of clinical trials under the direction of the Manager of Clinical Trial Operations and the Principal Investigator or designee.
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The successful candidate will work under the direction of the Principal Investigator of the Laboratory of Vascular Thrombosis and Inflammation. The faculty in the NHLBI DIR is an outstanding group of internationally recognized biomedical researchers covering a wide range of basic and clinical research topics (please see ) complemented by the other research institutes within the DIR (please see.
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clinical investigator jobs in Washington, DC
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