Recognizes when agreements are necessary within the research Contracts and program and facilitates the process, by coordinating with teams Agreements and appropriate Duke offices. Independently develops protocols for all studies, including those that Protocol development are complex in nature. May provide oversight and conduct training in this area. Independently navigates conversations with foreign agencies and Regulatory compliance study teams to develop or obtain the required documentation for with international compliance with international regulations. May assist others with studies ensuring regulatory compliance with international studies. Interacting with the Serves as an IND submissions expert resource. Assists junior staff to FDA as it relates to address FDA review or issues. Provides oversight and guidance to Duke Investigator held those preparing documents, annual reports, and amendments required by FDA. IND/IDE Use and development Develops, oversees adherence, and trains on SOPs for processes of SOPs across research program. Seeks out, integrates, and applies new technical knowledge towards Technology innovation and performance improvement for research program, as Management relevant. Prepares for and leads research program meetings. Ensures good Team meetings and communication within the research program, including mentoring management staff to improve communication strategies. Electronic management Oversees use of systems and system reports to manage of research participants patient/participant research activities and charge routing. Identification and Ethics/Participant Ensures that research program team members are appropriately Documentation of identifying and documenting adverse event information. Adverse Events Safety Ensures that multiple study teams are appropriately submitting AE Adverse Event Reports, according to institution and sponsor-specific prompt Reporting reporting requirements. Serves as an expert data flow resource to research program team members. Predicts areas of data flow vulnerability. Determines areas Data flow where data provenance may be compromised, and helps staff work through solutions. Ensures that staff are familiar with data flow resources at Duke.
Contracts and Agreements Recognizes when agreements are necessary within the research program and facilitates the process, by coordinating with teams and appropriate Duke offices. Protocol development Independently develops protocols for all studies, including those that are complex in nature. May provide oversight and conduct training in this area. Regulatory compliance with international studies Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Interacting with the FDA as it relates to Duke Investigator held IND/IDE Serves as an IND submissions expert resource. Assists junior staff to address FDA review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by FDA. Use and development of SOPs Develops, oversees adherence, and trains on SOPs for processes across research program. Technology Management Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for research program, as relevant. Team meetings and management Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies. Electronic management of research participants Oversees use of systems and system reports to manage patient/participant research activities and charge routing. Ethics/Participant Safety Identification and Documentation of Adverse Events Ensures that research program team members are appropriately identifying and documenting adverse event information. Adverse Event Reporting Ensures that multiple study teams are appropriately submitting AE Reports, according to institution and sponsor-specific prompt reporting requirements. Data flow Serves as an expert data flow resource to research program team members. Predicts areas of data flow vulnerability. Determines areas where data provenance may be compromised, and helps staff work through solutions. Ensures that staff are familiar with data flow resources at Duke.
readiness_tool_rpl_sep_2017_0.docx