RESEARCH PROGRAM LEADER

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

This position will manage two major programs in the Pulmonary division: 1. Duke Interstitial Lung Disease (ILD) Program which comprises of treatment clinical trials, as well as research on the effect of the environmental factors on this disease. 2. Duke Pulmonary Vascular Disease Program which has a diverse portfolio of industry sponsored clinical trials as well as PI initiated projects with industry and federal funding. It will provide oversight for the conduct of multiple research projects from initial proposal development and start-up, budget development and financial management, IRB and regulatory submissions and maintenance, database development, subject enrollment and data collection through closeout. In addition, this position will have active contribution to manuscript preparations and poster presentations; it will also facilitate research collaborations with various institutions and organizations.

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.
• Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).
• Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes.
• 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).
• Serves as an expert to research program team members in the area of screening. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio.
• 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. 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 effective facilitation of research program meetings in order to achieve objectives. 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. 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