- Cedars-Sinai (Santa Monica, CA)
- …meetings. + Works closely with investigators and regulatory staff or directly with Institutional Review Board ( IRB ) to submit adverse events, serious ... to successfully implement research protocols, in compliance with all regulatory requirements. **Primary Duties and Responsibilities:** + Responsible for… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing...applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are… more
- Cedars-Sinai (Los Angeles, CA)
- …for long-term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board ( IRB ) including submission of Adverse ... and patient research billing. This role will follow all federal, local, FDA, IRB , and HIPAA guidelines and regulations pertaining to the study and patient care.… more
- Stanford University (Stanford, CA)
- …strategies for recruitment, data quality control procedures and processes). May follow up with Institutional Review Board ( IRB ) to ensure renewals are ... managing IRB documentation. + Maintaining research team adherence to regulatory requirements. + Familiar with or interested in developing project management… more
- Stanford University (Stanford, CA)
- …and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. + Assemble study ... documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor visits and … more
- Stanford University (Stanford, CA)
- …and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed. + Assemble study ... documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor visits and … more
- Stanford University (Stanford, CA)
- …and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. + Monitor expenditures ... with Microsoft Office, REDCap and database applications + Demonstrated knowledge of regulatory requirements including Institutional Review Boards, HIPAA and… more