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As a Junior Clinical Research Coordinator, you are responsible for assisting with the management and coordination of all aspects of conducting clinical trials within s RII, surgery centers, both clinically and administrative/regulatory.
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Provides study start-up documents (paper or electronic) to Clinical Research Regulatory Coordinator. Supports the Clinical Research Regulatory Coordinator in the maintenance of regulatory documents in accordance with SOPs. Develops accurate source materials and ensures compliance from study team.
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As analytical development relates to quality, process development, preclinical and clinical R&D, manufacturing, and regulatory functions, there is opportunity for exposure to the whole scope of biopharmaceutical industry processes.
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Proven track record of being able to successfully interact with all levels of area, affiliate and internal authority across divisions (including Global Commercial Leaders, Forecasting, Clinical Development, HEOR, Medical Affairs and Regulatory, as well as peer equivalents in other market access teams and the market access community as a whole.
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Responsible for keeping abreast of regulatory Hospital, CMS, OPTN/UNOS policies, and ongoing clinical education in transplant and evidenced based research. As a Lead Transplant Coordinator RN, you will have the opportunity to engage in collaborative, interdisciplinary research activities.
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Ensure strong relationships with key stakeholder functions including Analytical Development, Cell Culture, Purification, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic input.
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The ideal candidate will direct and assist research staff daily in screening and enrolling patients in randomized clinical trials per study protocol. UTHealth Houston includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Act as a resource for the research studies' regulatory activities including, but not limited to, interpreting, preparation, coordination, implementation and compliance with the Institutional Review Board (IRB) guidelines, FDA requirements, and Good Clinical Practice procedures.
$82,500 - $120,000 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Fostering collaboration with biomarker and companion diagnostic partners: You will work closely with scientists, regulatory experts, and clinical and biomarker operations teams to ensure alignment of requirements and logistics across clinical trial protocols.
$122,800 - $193,300 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Working knowledge of FDA regulatory policies, procedures and requirements, Good Clinical Practice, ICH guidelines. BS, BA in life science, medical or equivalent; minimum of 8 – 10 years of operations management in clinical research in medical device / med tech industry or clinical research site-based experience.
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We provide strategic guidance and testing services – from research to release - leveraging our preclinical testing, CMC/technical services, and clinical research experience to deliver exquisite science, develop valuable insights, and author flawless documentation.
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. TMAC’s direct-hire service, formerly known as TMAC Direct, is an award-winning executive search firm that specializes in permanent placement services for the Pharmaceutical, Biotech, Diagnostics, Device, and Life Science Research industries.
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Collaborate cross-functionally with research, clinical, and regulatory teams to identify and prioritize biomarker strategies aligned with therapeutic goals. Author and review scientific publications, regulatory documents, and presentations related to biomarker research.
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He/She will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors.
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