- Houston Methodist (Houston, TX)
- …laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board ( IRB ), Food and Drug ... forms and associated documentation + Serves as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure… more
- Houston Methodist (Houston, TX)
- …laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board ( IRB ), Food and Drug ... and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP)...study personnel. + Acts as a liaison between the institutional review committees, regulatory agencies, and the… more
- MD Anderson Cancer Center (Houston, TX)
- …research, such as informed consent, patient confidentiality, and the procedures for obtaining institutional review board ( IRB ) approval. Also, ... such as informed consent, patient confidentiality, and the processes for obtaining Institutional Review Board ( IRB ) approval. Participation in the… more
- Methodist Health System (Dallas, TX)
- …the IRB . * Create and/or adapt clinical trial informed consent documents for Institutional Review Board ( IRB ) submission. * Maintain regulatory ... growth * Be engaged and eager to build a winning team * Review clinical research protocols to determine logistical components of regulatory requirements * Obtain… more
- Sam Houston State University (Huntsville, TX)
- …compliance with Health Insurance Portability and Accountability Act ( HIPAA ), Institutional Review Board ( IRB ), Family Educational Rights and Privacy ... Act ( FERPA ), and institutional policies. Provides consultation and technical support to research...and publication. Supports data elements in grant proposals and IRB submissions; may be listed as key personnel on… more
- Sam Houston State University (Huntsville, TX)
- …the proper conduct of informed consent procedures in accordance with Institutional Review Board ( IRB )-approved protocols. Collects and enter clinical ... environment. Maintains study documentation and support regulatory compliance, including IRB submissions and adverse event reporting. Coordinates with external sites,… more
- ICON Clinical Research (Austin, TX)
- …document collection and TMF reconciliation with site files + Support sites with local Institutional Review Board ( IRB )/Ethics Committee (EC) submissions ... and confirm approvals + Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution + Independently… more
- Baylor Scott & White Health (Fort Worth, TX)
- …and standards of JCAHO, federal, state and local governments. Submits documentation to the Institutional Review Board ( IRB ) autonomously and follows the ... of the Role** + Coordinates non-therapeutic (ie minimal risk, survey, chart review ) clinical research protocols with direction from the principal investigator and/or… more
- Houston Methodist (Houston, TX)
- …to the sponsor and data archiving. + Collaborates and prepares with Principal Investigator, Institutional Review Board ( IRB ) and regulatory documents for ... submission assuring compliance with local and federal regulatory standards as appropriate and required by the research protocol. Follows International Council for Harmonisation/Good Clinical Practice guidelines. **FINANCE ESSENTIAL FUNCTIONS** + Assisting… more
- Baylor Scott & White Health (Austin, TX)
- …and exclusion criteria are met. + Partners and coordinates with regulatory compliance. Prepares Institutional Review Board ( IRB ) materials for protocol ... all trial phases, from pre-study to closure, following federal, state, and Institutional guidelines. This position will learn to assist on complex studies and… more