- Johns Hopkins University (Baltimore, MD)
- …when necessary. Write responses to audit reports with input from the Principal Investigator . + Maintain compliance with HIPAA and IRB regulations and guidelines. ... protocol submissions, develop consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations + Serve as… more
- Stanford University (Stanford, CA)
- … compliance . Regularly inspect study document to ensure ongoing regulatory compliance . + Work with principal investigator to ensure Investigational New ... work. + Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing… more
- Stanford University (Stanford, CA)
- … compliance . Regularly inspect study document to ensure ongoing regulatory compliance . + Work with principal investigator to ensure Investigational New ... work. + Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing… more
- University of Pennsylvania (Philadelphia, PA)
- …forms and source document tools, as well as, to provide direct regulatory/ compliance guidance and facilitate investigator initiated trials and investigator ... in study team meetings, research team meetings, and ongoing protocol training/ compliance meetings. The Regulatory Affairs Specialist-CC is expected to facilitate the… more
- University of Washington (Seattle, WA)
- …including: Implement research protocols by writing and maintaining SOPs to maintain Investigator and Patient compliance . Monitoring patient adherence to the ... Guide MDs with all aspects of the development of investigator initiated studies. Where required, assist MDs with retrospective...Must be familiar with all aspects of regulatory and compliance functions: initial submission to SRC, IRB, CRBB/OSP as… more
- HonorHealth (AZ)
- …review requests, protocol deviations, and information required from the Principal Investigator . Audits compliance of policies and documentation requirements for ... Coordinates all activities related to the Institutional Review Board and assures compliance with IRB guidelines and FDA regulations. In accordance with (45 CFR… more
- Johns Hopkins University (Baltimore, MD)
- …guidance and support to a diverse group of investigators ensuring compliance with commercial and investigator -initiated sponsored projects. This position ... is carried out in strict accordance with Standard Operating procedures and in compliance with Good Clinical Practices. + Works with investigators, the Office of… more
- University of Miami (Doral, FL)
- …Form and all source documentation required to determine eligibility and maintain compliance . 14. Works closely with the Investigator , Investigational Pharmacist, ... of quality, safety, and service while ensuring population-specific patient care and compliance with the research protocol in an ambulatory setting. The Clinical… more
- University of Miami (Plantation, FL)
- …Form and all source documentation required to determine eligibility and maintain compliance . 14. Works closely with the Investigator , Investigational Pharmacist, ... assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls… more
- University of Pennsylvania (Philadelphia, PA)
- …forms and source document tools, as well as, to provide direct regulatory/ compliance guidance and oversight of investigator -initiated trials and investigator ... in regulatory staff meetings, research team meetings, and ongoing protocol training/ compliance meetings. The Regulatory Affairs Start-Up Specialist- is expected to… more