Research Program Leader, Duke Cancer Institute

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.

Research Program Leader [RPL]

Oncology Clinical Research Unit [CRU]

Supportive care & survivorship center [CS]

Position Description , 04/2024

Occupational Summary

Provide leadership in the development, implementation and management of research for the Duke Cancer Institute’s [DCI] Supportive Care & Survivorship Center (SC & Center).  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 – 40% Effort

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 – 20% Effort

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 – 20% Effort

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 – 10% Effort

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.  

Supervisory – 5% Effort

Lead, supervise and manage staff including coaching, mentoring, time-off, annual performance review, performance management, career development, training, hiring and termination.  Collaborate closely with DCI HR in all aspects of staff management. 

Create a team culture that fosters open communication, motivates and retains staff, and encourages creativity.  Communicate regularly with staff both as a team and individually.  Provide staff with clear measurable goals, monitor performance and quality of work.  Ensure staff training and certifications comply with standard operating procedures [SOPs] and regulations that govern clinical research and protocol requirements.  Cross-train and reassign work as business needs dictate. 

Ethics – 5% Effort

Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.  Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.  Maintain Duke and project specific training and certification requirements.

Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.  Articulate, to study staff and research participants, the reasoning for an individual protocol's inclusion and exclusion criteria.  Provide departmental-wide training in the ethical conduct of research.  Serve as an expert resource in study design to ensure inclusion of safeguards, protection of vulnerable populations and ethical conduct standards. 

Other work as assigned. 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Qualifications Required At This Level

Link to view the education, training, experience and skills required for a 1280 Research Program Leader position:  https://forms.hr.duke.edu/descriptions/university/select.php?ID=1280      

Completion of a Bachelor's degree

Work requires a minimum of four years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related

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Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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