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, shaping the future of medicine through cutting-edge research. The QC team for Cellular and Gene Therapy Operations seeks a skilled Quality Control Manager to oversee in-process and release testing for GMP
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strategy for recruitment and retention of their assigned trials. The Clinical Study Coordinator presents trial concepts and details to the research subjects, participates in the informed consent process
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accurate documentation throughout the research process. Compile and submit data according to protocol guidelines, ensuring compliance with study requirements. Actively recruit patients for studies and assist
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in to IRB clinical trials. Assess and document signs and symptoms of illness, reactions to treatment, changes in physical or psychological condition and general appearance in accordance with the IRB
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negotiation and development, and performing necessary performance management to ensure project success within defined cost parameters. Process development and implementation Designs and develops systems
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determinations. Enter and/or review financial data in OnCore and initiate the sign-off process of the OnCore calendar/financial console. Review protocol amendments for any revisions affecting the coverage analysis
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process to ensure compliance with regulations. Conduct pre-reviews of submissions, ensuring completeness and compliance, coordinating timely reviews, preparing committee minutes, and issuing action notices
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data reporting requirements. Review and process invoices from sub-sites. Regulatory Responsibilities for Participating Sites: Manage deviation, adverse event, and unanticipated problem reporting. Systems
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consent documents · Coordinate responses during the protocol approval process, interfacing with internal stakeholders Your qualifications should include: · Master's degree or Bachelor's degree
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. The successful candidate: Hours: Part time, Thursdays only (12hrs per week) Performs all tasks related to the EHR admission/discharge process of outpatient and inpatient visits. Performs accurate patient