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 tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Oncology Clinical Research Unit [CRU]
Bone Marrow Transplant, Hematology Malignancies &
Cellular Therapy Clinical Research Programs [BMT]
POSITION DESCRIPTIONOCCUPATIONAL SUMMARY Provide leadership in the development of research concepts and implementation of the concept into research study protocols for the Duke Cancer Institute’s [DCI] Heme/BMT Oncology Clinical Research Program [Heme/BMT]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research. WORK PREFORMED Operations, Study and Site Management – 60% Effort Work closely with the Principal Investigator [PI] and investigative team on study feasibility, design, protocols, and recruitment and retention strategies; evaluating and making appropriate recommendations. Evaluate and include cultural diversity and competency in study design and conduct. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Develop safety and security documents such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP]. Responsible guiding studies through the Institutional Review Board [IRB] process including documents and communication. 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. Develop initial draft budgets for investigator initiated and industry sponsored studies and work with finance manager to successfully negotiate payment terms with sponsors and funding companies. Lead the study startup process, including coordinating or drafting feasibility, budgets, contracts, billing grids and Beacon builds. Take part in site initiation and closeout visits. Prepare for closeout and document storage. Science – 10% Effort Conduct literature reviews independently. Collaborate with stakeholders [statistical, operational, etc.] to ensure adequate design, implementation and testing of study aims. Identify operational shortcomings of proposals and protocols; make recommendations. Develop research proposals or protocols with little assistance. Summarize study results. Assist in manuscript writing. Participate in scientific presentations and publications. Communication – 10% 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 Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Serve as an expert resource for colleagues, teammates, sponsors, subcontractors and vendors. Support colleagues in their project work; encourage completion. Assist colleagues in identifying efficiencies and improving process. Actively network. Encourage career development by actively seeking out continuing education opportunities.
Supervisory – 10% EffortManage and supervise assigned staff. Assign and overseeing day-to-day assignments, work schedules, time off requests, yearly evaluation, hiring, and performance management for staff. Model the DCI’s core value “Cancer Care as It Should Be” for staff. Create a team culture that fosters open communication, motivates staff, and encourages creativity. Seek out, listen to, accept and act on feedback. Establish regular communication methods and meetings with staff; collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring. Provide staff with clear measureable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research. Ensure staff collaborate closely with the regulatory, nurse, coordinators and data teams. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. Ethics – 10% Effort Articulate, to study staff, the pathophysiology or 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. Summarize and clarify for study teams, 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. Other work as assigned. Skills Knowledge of therapeutic research design. Ability to effectively collaborate and communicate with diverse communities to move projects forward. 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. Preferences
The preferred candidate will have experience in research and regulatory.
QUALIFICATIONS REQUIRED AT THIS LEVEL Education/Training Completion of a Bachelor's degree ExperienceWork requires a minimum of four years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.Skills Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].
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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.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.