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.

 

 

Occupational Summary

Provide leadership in the development, implementation and management of research for the Duke Cancer Institute’s [DCI] Phase 1 Clinical Research Program [PH1]; the Oncology Clinical Research Unit [CRU] provides research oversight.  Serve as the primary liaison throughout the institution for assigned projects.  Responsible for managing projects through the entire lifecycle, from concept to initiation to closeout: responsible for project results including costs and reporting. 

 

Work Preformed

Program, Project and Study Management

• Work closely with the Principal Investigator [PI] and research team on goals, study feasibility, design, protocols, resources, and recruitment and retention strategies.  Evaluate plans, processes and results to make recommendations for improvement; develop and implement solutions.  Contribute expertise in research design to develop protocol and research proposals.  Evaluate and include cultural diversity and competency in study design and conduct. 
• Assist with budget development; monitor and adhere to the established budget. 
• Participate in, and provide oversight, including communication, for IRB submissions and documentation, regulatory and safety reporting, and adverse events.   Coordinate Duke core services such as Investigational Drug Service [IDS] and Biobank.  Be familiar with intellectual property rights, inventions patents, and technologies.  Understand regulations related to investigational products with sponsors.  Manage agreements such as Material Transfer and Investigational New Drug Applications. 
• Assist with the development, selection, and implementation of data capture methods and protocol-specific systems and documents.  Oversee the design of data forms such as; electronic case reporting forms [ECRF], electronic data capture [EDC], data flow, queries, quality assurance, and data security.  Develop safety and security documents such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP]. 

Science

• Collaborate with stakeholders [statistical, operational, etc.] to ensure adequate design, implementation and testing of study aims.  Develop research proposals or protocols with little assistance.  Summarize study results.  
• Contribute significant writing and editing to grant and funding proposals and the development of investigator-initiated studies.   Read and analyze literature to assist with manuscripts.  Keep current on scientific advances. 

Communication

• Collaborate, and communicate with PI and study personnel as required.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Escalate issues to others as appropriate.  

Leadership

• Serve as an expert resource for colleagues and teammates.  Assist colleagues in identifying efficiencies and improving process.  Support colleagues in their project work; encourage completion.  Actively network. 
• Provide leadership within the team.  Mentor staff.  Prepare for, lead and participate in team meetings, committees, task forces and ad hoc groups.