- Beth Israel Lahey Health (Boston, MA)
- …with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins ... of study administration at the enrolling sites including maintenance of and compliance with the study protocol; study site and project committee communication,… more
- Vanderbilt University Medical Center (Nashville, TN)
- …efficient invoicing and taking appropriate action to maintain clinical trial billing compliance . + Assists the Principal Investigator in the development of ... enrollment goals and initiates strategies to promote enrollment and participant compliance . + Supervises, mentors and trains new or junior research staff/interns.… more
- Beth Israel Lahey Health (Boston, MA)
- …with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins ... record. Verifies information with clinical research nurse and/or principal investigator . (essential) 3. Discusses informed consent with research subjects. Interacts… more
- Stanford University (Stanford, CA)
- … compliance . Regularly inspect study document to ensure ongoing regulatory compliance . + Work with principal investigator to ensure Investigational New ... Original, and Accurate). Their role is crucial in maintaining the study's compliance , accuracy, and overall success in ICU patient research. At Stanford University… more
- IQVIA (Indianapolis, IN)
- …for resolution + Review CAPA and Effectiveness Check plans; ensure accuracy and compliance + Support derogatory investigator status tracking and database updates ... under the direction of senior QA staff. This role ensures regulatory compliance and strengthens operational excellence within a dynamic laboratory setting. **What… 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
- 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
- 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
- Beth Israel Lahey Health (Boston, MA)
- …physicians, nurses and fellows. Learns to identify any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to ... medical record. Verifies information with clinical research nurse and/or principal investigator . 3. Learns about informed consent and assist in discussion with… 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