- IQVIA (Carlsbad, CA)
- …a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront ... Quality Assurance: Assess site practices for protocol adherence and regulatory compliance , escalating quality issues as needed. Study Progress Management: Oversee… more
- Rubrik (Palo Alto, CA)
- …environment. **What you'll do:** + Lead and act as the primary investigator during incident response (IR) activities, leveraging expertise in enterprise forensics. ... NIST, SANS). + Demonstrable experience working in environments subject to FedRAMP compliance (eg, experience with NIST SP 800-53, FedRAMP controls, JAB/Agency ATO… more
- Gilead Sciences, Inc. (Foster City, CA)
- …amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). + Oversees and approves the authoring of ... regulatory documents, including meeting requests, Module 1 documents for original IND, etc. + Oversees and...required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures… more
- Cordis (Irvine, CA)
- …Ensures accuracy, validity, and completeness of data at trial sites in compliance with the protocol, clinical monitoring plan, informed consents forms and associated ... and associated training documentation is available in the site's investigator file and sponsor trial master file + Contribute...into trial activities, such as trends in enrollment, protocol compliance , and data quality. Escalate site issues to the… more
- Stanford University (Stanford, CA)
- …seeking a Research Coordinator & Lab Manager working remotely and required to go on-site 1 day or less per week. This position will perform duties related to data ... study related documents, and complete study documents/case report forms. + Ensure compliance with research protocols, and review and audit case report forms for… more