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.
Site Visits and Sponsor Training Leads site initiation and closeout activities. Provides feedback to study team members and serves as an institutional resource to the site visitors. Operational Ensures the appropriate development and implementation of standard operating procedures within the research program. Study Closeout with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines. Program/Portfolio *Program and portfolio oversight and management Manages the program or shared resource by employing strategies to reach established short- and long-term goals. Monitors the program's success using relevant reports. Investigates trends and implements modifications to improve the effectiveness of the research program or shared resource. *Infrastructure planning and management Manages the research program or shared resource operations. Monitors and adheres to the established budget. Manages and trains staff. *Program liaison and communication Ensures that institutional communications are shared with research program staff. Maintains communication within program and with other departments or offices to accomplish the program objectives. Leadership competencies Competency Do I meet or exceed? How? Continual Learning Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the of staff retention, continuous improvement, and development.