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Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, regulatory documents, and other study-start-up requirements in partnership with the study PI and study team.
$66,700 - $103,400 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols.
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Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Familiarity with UCSF processes and systems; knowledge of CHR/IRB policy and procedure. The Center for Cerebrovascular Research (CCR) is a core group of faculty and staff pursuing integrative and interdisciplinary studies of cerebrovascular disease, utilizing the tools of cell biology, animal models, human genetics, epidemiology and treatment outcomes research.
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Protocol Submissions: Prepares and reviews clinical trial documents for submission of new and amended or modified documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), sponsor or supporters and other approving entities.
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Assisting the Principal Investigator with Institutional Review Board (IRB) submissions, IRB compliance, and progress reports. The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters.
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Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology. Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Develops and maintains a pre-review program that will coincide with the IRB, IACUC, SRS, IBC, CIRB, and/or R&D Committee review of all research involving human subjects, animal subjects, basic laboratory science and the human research protection program.
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Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines. There is an exciting opportunity within the Precision Medicine Biomarker Program Management (BPM) group at AbbVie. The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials.
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Proficient knowledge of IPv4 and IPv6 Networking, Routing (OSPF/BGP/ISIS/PIM) and Switching (STP/SVI/VLAN, IRB/BVI) Cisco Certified (CCNP, CCIE) - Industry and vendor specific certifications and training preferred (Cisco, Juniper, Nokia, etc.
$124,000 - $220,000Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings. The ideal candidate is an MD or MD/PhD scientist with a clinical perspective, coupled with a track record of exceptional achievement in oncology therapy development.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Research Assistant may also coordinate meetings with early intervention providers and Directors of Early Intervention programs in the Greater Boston area, assist with data collection from early intervention providers; review and score recorded intervention sessions for intervention fidelity and code recorded parent-child interactions for parent responsivity, manage and administer participant incentives, and manage Institutional Review Board (IRB) submissions.
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Assists with Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews.
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Represents the Radiation Safety Office as a subcommittee representative (i.e. IACUC and RITN) and reviews IRB and IACUC protocols. The Physicist manages the daily operation of radiation safety office and directly reports to the Chief Radiation Safety Officer.
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Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy.
ExpandApply NowActive JobUpdated 6 days ago
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