- BeOne Medicines (San Mateo, CA)
- …regional study budgets + Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities + ... Identifies and manages regional team resource needs and establishes contingency plans for key resources + Monitors regional resource utilization over study life cyle and liaises with functional managers as needed **Supervisory Responsibilities:** + Provides… more
- Cedars-Sinai (Los Angeles, CA)
- …author of peer reviewed articles, with ability to serve as principal or co- investigator + A track record of excellence in teaching, patient care, research (clinical ... or basic) and administration **About Us** Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in… more
- Cedars-Sinai (CA)
- …and intelligibly communicated to the researchers; conducting staff evaluation of investigator 's response to identify potential issues for IRB reviewers; issuing ... approval documents; and maintaining accurate updates in the Departmental online submission and tracking system. + Advises investigators and research staff on federal regulations and IRB submission requirements and assisting them, as needed, in the preparation… more
- University of Southern California (Los Angeles, CA)
- …Manage financial aspects of clinical trials, including budget tracking, investigator payments, invoices, and financial reporting for sponsors. + Proposal ... Development: Assist principal investigators (PIs) in preparing administrative components of grant proposals within sponsored and non-sponsored research guidelines. + Budget & Financial Oversight: Develop, prepare, and monitor project budgets, ensuring… more
- Abbott (Alameda, CA)
- …adherence to protocols and determines study completion. + Coordinates and oversees investigator initiations and group studies. + May act as consultant/liaison with ... other corporations when working under licensing agreements. **Required Qualifications** + Bachelor's degree + Minimum 8 years of relevant experience **Preferred Qualifications** + Master's or PhD degree in science or a related field. + Experience with quality… more
- Cedars-Sinai (Los Angeles, CA)
- …etc.). + Organizes clinical/research trials in conjunction with the Principal Investigator and sponsor and/or funding source. + Monitors and ensures compliance ... with safety standards and procedures. + Analyzes data and prepares scientific findings for publication as author or co-author. + May make independent presentations. + May provide system administration and maintenance for the local workstation network. + Leads… more
- BeOne Medicines (San Mateo, CA)
- …the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide comments on new ... global guidance through company's commenting process. **Supervisory Responsibilities:** The position may or may not manage direct report(s). **Computer Skills:** Microsoft 360, Familiarity with Veeva is a plus. **Qualifications:** + 8+ years of related… more
- BeOne Medicines (Emeryville, CA)
- …concepts, synopses, protocols, and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts ... + Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports +… more
- BeOne Medicines (San Carlos, CA)
- …specification, IRC integration specification, DTS etc. and provide training to investigator sites as needed for sample collection schedule, sample processing and ... shipment, etc. + Participate in clinical study team meetings, providing updates and insights related to biomarker activities and progress **Supervisory Responsibilities:** + NA **Computer Skills:** Proficient in MS office **Other Qualifications:** + 6+ years… more
- University of Southern California (San Diego, CA)
- …remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent ... Forms, and other monitoring visit activities. + Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. + Review study data, issue and resolves queries.… more
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