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Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions.
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Coordinates scheduling and set up for audits and all Monitor, study start-up, and close out visits. -Compiles and monitors information necessary for continuing review by local IRB or for Network Principal Investigator annual continuing review for USOR trials.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Support regularly document development, including editing Sponsor documents to match OHSU requirements, as part of study start-up. This TI clinical research assistant II position will support study coordination for several clinical trials and infectious disease epidemiological studies focused on the natural history of NTM, HIV, yellow fever, and other infectious diseases.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all 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.
$61,242 - $86,121 a yearExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Study Coordinator, Clinical Research Coordinator, Clinical Research Regulatory. Min 2 yrs exp in a clinical research coordinator role, College Degree, exp with IRB procedures, recruiting and enrolment, completing CRFs.
$30 - $35 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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. Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities.
$130 - $160 an hourInternExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Maintain all regulatory documentation, including local or central IRB and study data. Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes.
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Coordination may also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, IBC, CHPS) for initial approval, continuing reviews and for approval of any amendments.
$66,000 - $100,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Reviews and finalizes documents based on IRB comments and recommendations and ensures IRB approval of study. Relevant certification as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) upon hire or within six months of hire.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Assists with scheduling for monitoring visits, study start up visits, close out visits, and audits as needed. Works closely with US Oncology Regulatory and Sponsors in coordination of study start-up and closure procedures.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Monitors the occurrence of clinical adverse events, reporting any to the PI, the study sponsor and Institutional Review Board (IRB). Responsible for assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Clinical Research Coordinator assists the clinical trials process by registering hematology, oncology, and bone marrow transplant patients for clinical studies, assessing eligibility criteria, maintaining current protocol packets and assuring that all quality assurance measures are maintained within the protocol/study.
$39,300 - $64,349 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing.
Full-timeExpandApply NowActive JobUpdated 9 days ago
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