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This position will manage activities pertaining to the Protocol Review and Monitoring Committee (PRMC) which primary goal is to ensure that institutional, industry-sponsors, and externally peer reviewed cancer research studies involving human subject conducted under the auspices of the SCCC are (1) scientifically and statistically sound; (2) appropriately designed; (3) feasible for completion; and (4) if applicable, in compliance with NIH guidelines for clinical trials.
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In partnership with the Office of Research Affairs and Research Compliance ensures Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, Principal Investigator, and regulatory agency specifications.
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IRB: UCLA’s Institutional Review Board (Application to Involve Human Subjects in Research form, study-specific Informed Consent Form, HIPAA Authorization, subject recruitment documentation and requests) c.
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Experience in a research/lab animal/GLP environment. Provide support for activities of the Institutional Animal Care and Use Committee (IACUC), including protocol review, program review and facility inspections.
$145,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate including initial submissions, amendments, continuing reviews, adverse events and serious adverse events.
$43,919 - $55,294 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Minimum one year of experience in a clinical research regulatory affairs and/or an oncology related field required. Under general supervision is responsible for supporting the regulatory team with coordinating the research regulatory and administrative activities of clinical trials for the practice.
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Coordinates non-therapeutic (i.e., minimal risk, survey, chart review) clinical research protocols with direction from the Principal Investigator and/or senior staff in compliance with regulatory laws and institutional guidelines.
$49,850 - $70,419 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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This work includes coordination of regulatory activities and aspects of collection and management of data for research protocols related to treatment, ancillary services, and prevention practices.
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Assist or lead preparation of deviation reports and the completion of resulting corrective and preventative actions (20%) Assist or lead program improvement including identification of recurring deviations and/or gaps in the quality program and initiation or revision of SOPs related to the data review and QC processes followed for Animal Rule/GLP studies (15%) Participate in QA, sponsor, and/or regulatory agency (e.g. FDA) audits (5.
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In this role, you will be responsible for preparation, submission and maintenance of regulatory applications to fulfill research requirements for open studies in addition to working with Sponsor monitors to timely process, review and collect regulatory documents maintained in the Investigator Site File. All work should be completed according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) and government regulations.
$24.28 an hourFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Assists in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities.
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The CN is accountable for compliance with the Ohio Nurse Practice Act, applicable regulatory standards, and institutional policies and procedures. The CN is responsible for maintaining high standards for a caseload of patients as described by the scope of care for the area of practice and demonstrates appropriate actions based on sound scientific research and evidence-based principles.
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The AVP also oversees pre-award compliance and the Institutional Review Board (IRB), the Institutional Animal Care & Use Committee [IACUC], and the Unmanned Aircraft Systems Review Board (UASRB.
$14,167 - $29,425 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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This position will provide oversight of the Institutional Review Board, National Institute of Health Clinical Trials, and UNC regulatory processes. Demonstrate a strong working knowledge of research, regulatory compliance, and clinical trials.
$70,972 - $90,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Knowledge of, and experience with, Duke institutional policies and processes regarding clinical research, setting up contracts with independent contractors and vendors, institutional reliance agreements, and data privacy and protection.
Full-timeExpandApply NowActive JobUpdated 19 days ago
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