Research Program Leader - Psychiatry - Child Div - Posner Team

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations: 
For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Serves as an expert resource across all study teams within the research portfolio for navigating regulatory compliance with international studies. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level  documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). Provides training. Serves as an expert to research program team members in the area of screening. May provide oversight and conduct training in this area. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies.

Ethics: 
Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:
Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related