- Stanford Health Care (Palo Alto, CA)
- … guidelines, policies and procedures when providing care. Ensures adherence to GCP, ICH, FDA and other regulatory agencies in the conduct of clinical research. + ... the consent process to ensure it is performed in compliance with institutional, FDA , IRB, clinical trial sponsor and other applicable regulations. + Oversees and… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... efficiency of study related data capture. Moreover, the CRC2 will oversee quality control, ensuring that team members' data collection complies with Good… more
- University of Colorado (Aurora, CO)
- …as appropriate; responds to queries from Sponsor + Adhere to research regulatory standards + Maintain detailed records of studies including Patient Source Document ... ensure compliance with requirements of the Food and Drug Administration ( FDA ), study protocols, department, hospital/clinical standard operating procedures and other… more
- Lilly (Indianapolis, IN)
- …+ **Compliance** : Ensure that all systems and equipment meet **GMP and regulatory standards** ( FDA , EMA, etc.) from design through validation + **Support ... the project engineering team at IRLT aligned with corporate goals, regulatory expectations, and operational readiness. This includes: + **Qualification and… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... is to achieve the goals of providing the highest quality of clinical services to the patients for whom...and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing… more
- Kelly Services (Bristol, TN)
- …and data integrity requirements. + Knowledge of validation lifecycle principles, cGMP, FDA expectations, and regulatory compliance practices. + Capability to ... (Permanent)** **Location:** Bristol, TN **Reports to:** Technical Operations / Quality Leadership **Schedule:** Full-time, on-site **Salary:** **$80,000-$95,000/year** **Your Impact**… more
- Oracle (Lansing, MI)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... practices within your organization to develop and deploy high quality software at a rapid pace. You will identify...Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -… more
- AbbVie (North Chicago, IL)
- …for US and foreign patent prosecution, listing patents in the FDA 's Orange Book, analyzing freedom-to-operate issues, addressing contractual issues, evaluating ... Legal Academy Work on a wide range of clinical-trial related legal and regulatory matters in support of AbbVie's therapeutic pipeline. Provides support for AbbVie's… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory… more
- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... efficiency of study related data capture. Moreover, the CRC2 will oversee quality control, ensuring that team members' data collection complies with Good… more