Job Summary Under the direction of the Program Manager, Regulatory Affairs, this position coordinates, assesses, plans, 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 and scientific review groups.
Coordinate and/or review all submissions to the IRB (which may include multiple IRB's) and other required committees, including new protocol applications, protocol amendments, informed consent documents, progress reports, and serious adverse events (SAE) and Investigational New Drug (IND) Safety Reports. Review submission of protocols to Institutional Review Boards (internal and external). This includes exempt, minimal risk and greater than minimal risk human research protocols.
Understand and coordinate with the Program Manager Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies.
Develop of regulatory documents, including informed consent templates, and 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.
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.
Coordinate and/or review regulatory correspondence with FDA and other regulatory agencies as necessary; interact with FDA and other regulatory agencies on project-related issues, applicable policies and other relevant issues.
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: 2018-13265
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