- Cedars-Sinai (Los Angeles, CA)
- …federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board ( IRB ). **Primary Duties and ... local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board . + Maintains research practices using Good Clinical… more
- Stanford University (Stanford, CA)
- …for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. + Assemble ... clinical research. Responsibilities include preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations;… more
- Cedars-Sinai (Los Angeles, CA)
- …contact for long-term follow-up patients only. + Assists with regulatory submissions to the Institutional Review Board ( IRB ) including submission of ... 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
- Cedars-Sinai (Santa Monica, CA)
- …staff meetings. + Works closely with investigators and regulatory staff or directly with Institutional Review Board ( IRB ) to submit adverse events, ... research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. + Ability to use software applications (MS Office Suite -… 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 ... requiring judgment in applying non-routine procedures. + Analyze and summarize results for review with supervisor. Audit the accuracy and validity of data. + … more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + Hybrid work agreement. _*… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - Other duties may… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - Other duties may… more
- Stanford University (Stanford, CA)
- …regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to ... New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - Other duties may… more
- Stanford University (Stanford, CA)
- …for completion and accuracy with source documents. Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. + Assemble ... and recording of patient and research data in appropriate files per institutional and regulatory requirements. + Hybrid work agreement. + Participate in monitor… more