- 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)
- …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
- 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
- Houston Methodist (Houston, TX)
- …or other funding agency guidelines. + Ensures adherence to institutional policies, IRB ( Institutional Review Board ) protocols, and federal ... of those visitors into the research environment, ensuring compliance with institutional , federal, and international regulations while promoting a productive and… more
- Houston Methodist (Houston, TX)
- …quality and safety. **FINANCE ESSENTIAL FUNCTIONS** + Assures study conduct meets appropriate Institutional Review Board ( IRB ), Federal Drug ... Administration (FDA), Institutional Council of Harmonization (ICH)/Good Clinical Practice (GCP), and agency guidelines. + Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily… more
- Houston Methodist (Houston, TX)
- …notifies the PI of laboratory findings. **QUALITY/SAFETY ESSENTIAL FUNCTIONS** + Prepares Institutional Research Board ( IRB ) documents under the direction ... are available. This position will work with the Regulatory Affairs Office, the IRB and the physicians to coordinate the requirements needed for these expanded access… more