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Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
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Summary: The Clinical Trials Assistant plays a pivotal role in supporting clinical research teams to ensure efficient and effective study conduct. Coordinate Investigator payments, if applicable.
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The QAO assures that audit observations are documented and submitted to the appropriate Study Director/Principal Investigator, and to Management. Assists Study Directors/Principal Investigators in the preparation and review of Quality Assurance section of proposals.
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We are seeking an experienced Principal Investigator (PI) with a Rheumatologist / Rheumatology medical background to conduct and oversee studies. Ensure that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements.
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The Clinical Research Coordinator assists the investigator team to develop study protocols and manuals of procedures. The Clinical Research Coordinator screens, enrolls and follows study participants, conducts data collection and entry, and performs noninvasive cardiovascular tests according to study protocols.
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Assist with clinical study activities such as study start up, investigator meetings, data review, etc. Assist Clinical Scientist, Study Responsible Scientist (SRS), &/or Study Responsible Physician (SRP) in various clinical research assigned Immunology Development clinical trials.
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The range of tasks will include activities assigned by the Clinical Lead, Clinical Scientist and/or study physician, and may vary to some degree depending on the therapeutic area and trial-specific requirements.
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The Clinical Research Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.
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Verifies information with clinical research nurse and/or principal investigator. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse.
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Preparing study-related and/or safety-related documents and presentations. Enrolled in an accredited college/university pursuing a bachelor’s degree in life sciences, or be a recent college graduate or student enrolled in a master’s degree program in a relevant field.
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Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards.
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Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
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Under the direction of the Principal Investigator or designee, the Clinical Study Coordinator II – Ophthalmology is responsible for coordinating clinical research projects and providing direction for other research staff.
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Clinical Scientist Intern will support the Late Development Immunology team and will support further business, operational and clinical excellence in Immunology. Proficient with Microsoft Office, Word, Excel (including a high proficiency with generating pivot tables and graphs), and Power Point, and have strong oral and written communication skills.
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Responsible for implementing and maintaining global reporting practices for clinical adverse events, including, data collection and delivery, reconciliation and medical terminology coding for all program types including but not limited to clinical trials, non-interventional studies (NIS), Investigator Initiated Studies (IIS), Non Trial Activities (NTAs.
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