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Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
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Operations, Office of Sponsored Programs ("OSP"), Institutional Review Board ("IRB"), Institutional Animal Care and Use Committee ("IACUC"), Institutional Biosafety Committee ("IBC"), Quality Assurance and Education ("QA"), Billing Compliance, Privacy, and Financial Conflicts of Interest ("FCOI.
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Maintains communication with the SRC (Scientific Review Committee) and IRB (Institutional Review Board): annual updates, adverse events, safety reports, protocol amendment, consent modifications.
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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
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You will work closely with the IBC Chair, Institutional Contact for Dual Use Research (ICDUR) and Biosafety & Biogovernance Functional Area Manager (BBFAM) to define, analyze, implement, and make recommendations for continuous improvement of IBC and IRE business processes.
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Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB.
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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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The UMBC Research Compliance Program areas include Human Subjects Protections, Animal Care and Use, Institutional Biosafety Research, Export Control, Conflicts of Interest, Responsible Conduct of Research and supporting the Office of Research and Creative Achievement (ORCA) Vice President on requirements associated with allegations of misconduct in research and other scholarly activities.
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This position will serve as the Rowan Empowered Official for export controls and Deciding Official for research integrity, as well as being able to serve as the Institutional Official for the IRB, IACUC, and IBC. If you are interested in becoming part of a rising university and leading a dynamic Office of Research Compliance team, read over the job description below and apply.
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Thorough understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), and Institutional Review Board (IRB) policy.
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Works independently to prepare research-related protocols (pre-clinical, clinical, laboratory, and animal) for review by CRC/IRB/IACUC, including but not limited to initiation/submission/re-submission/termination utilizing PDOL and eResearch within institutional and departmental guidelines.
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Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
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Work Performed Operations, Study and Site Management – 48% Effort Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews. Maintain study compliance according to institutional requirements, protocols and other applicable policies such as NIH Public Access policy, ct.gov, and Research Data Security Plans.
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Familiarity with clinical trials, IRB protocols, remote data capture (e.g., REDCap, Qualtrics), and database management preferred. 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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They may assist with Institutional Review Board (IRB) filings, sponsor and investigator filings and research related presentations. Posted Job Title Clinical Research Coordinator B (Cardiovascular Institute) Job Profile Title Clinical Research Coordinator B Job Description Summary This position is in the Cardiac Electrophysiology Department which treats and studies the electrical component of the heart by way of ablation procedures and/or cardiac device implants (internal cardioverter defibrillator, pacemaker.
$43,919 - $52,661 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago
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