Job Summary This position coordinates and facilitates Regulatory Affairs at the Research Institute in the areas of training and compliance, system-wide use of Good Clinical Practice principals, and application of FDA and ICH guidelines. Responsible for the implementation and maintenance of study protocols from planning, through startup, lifecycle and closure. Studies range from industry-sponsored and investigator-initiated investigational agent, tissue acquisition, and chart/imaging review study protocols. Knowledge of clinical research trials regulations i.e., OHRP and the FDA, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) is essential.
Prepares and submits documents related to the protection of human subjects to the relevant IRB, scientific review groups and government agencies (FDA, CMS, NIH, etc.) for new study applications, study amendments, annual reports, IND Safety Reports, and other required regulatory documents. This includes HonorHealth-supported IND, IDE, HUD, HDE, and Compassionate IND Prepares informed consent documents, and any required regulatory documents.
Assist research staff and PIs in initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participate in direct discussions with the appropriate regulatory agencies and other parties. Assist physicians and other staff in meeting human subject protection standards in research. As necessary, participate in creation of supporting documents for research involving human subjects.
Assist in developing departmental operating procedures
Be knowledgeable of local, state and federal regulations that apply to human subject's research, including Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations, sponsor guidelines and all Standard Operating Procedures (SOP).
Interacts with the third party monitors for regulatory compliance and responds to regulatory queries.
Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents.
Review sponsor guidelines for each study to ensure compliance with Standard Operating Procedures; suggest modifications as necessary for compatibility.
Internal Number: 2018-14226
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