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Leads or collaborates on required tasks prior to commencement of senior clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with seniorclinical trial sites regarding all logistics including contract agreements, support materials and training.
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Troubleshooting and monitoring Mainframe storage utilizing CVantage, SMF records, SAS, Dcollect, SanNav, and Spectrum Control. Proficient with ICF Catalog maintenance, DFSMS and DFHSM. CDP’s Climate Change ‘A List.
$79,000 - $149,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines.
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Manage the creation and maintenance of critical study documents assigned to Clinical Development (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures (IB), Informed Consent Forms (ICF), Risk-Based Medical Monitoring Plan, Clinical Study Reports (CSRs), regulatory documents) with high quality and consistency with CDP, TPP and AskBio SOPs.
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Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, Manuscripts, and other relevant documents.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Responsible for the scientific and clinical inputs and review of study-related documents and analysis plans, including protocols, investigative brochures, informed consent forms (ICF), case report forms (CRF), associated data management documents, statistical analysis plans (SAP), independent Data Monitoring Committee (IDMC) and/or Study Review Committee (SRC) charters, and clinical study reports (CSR.
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Provide post-operative, routine or preventative medical treatments and interventions as per MD or RN order (i.e., G-tube feedings, wound and skin care, urinary drainage systems maintenance, blood glucose monitoring, passive and active range of motion therapy.
$60,000 - $62,400 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Prior clinical research or related experience (e.g. monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience) Provide regional medical & scientific input on trial outlines, trial protocols and ICF.
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Works with Finance Team including CFO and local administration in budget development, fiscal monitoring, and timely completion of documents related to census, billing data, appropriate revenue opportunities.
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Provide on-site, individualized, group, and virtual TTA to recipients related to governance, program management, and fiscal operations, including supporting recipients in the following areas: Correction of areas of noncompliance and deficiencies identified through the federal monitoring process.
RemoteExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Training & Monitoring of non-medical staff on g-tube feeding & medication administration, Foley Catheter, and Colostomy Bag. Training & Monitoring of non-medical staff on g-tube feeding & medication administration, Foley Catheter, and Colostomy Bag.
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Participates in study design and execution by contributing operational experience: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable.
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Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards.
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Maintains optimal health care for ICF individuals by administering medication and medical treatments, and monitoring health status. Maintains optimal health care for ICF individuals by administering medication and medical treatments, and monitoring health status.
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RESPONSIBILITIES The Program Manager is responsible for overall operation of one ICF-DD Management: Is responsible for the training, supervision, evaluation and management of the House Supervisor and Direct Support Professional staff.
ExpandApply NowActive JobUpdated 9 days ago
icf monitoring jobs
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