School of Nursing:
Established in 1931, Duke University School of Nursing is among the top ranked of the nation’s nursing schools. The School is proud of its overarching commitment to transform the future of nursing to advance health in individuals, families and communities. Members of the School of Nursing are part of an inclusive community that supports the professional goals of its people as they pursue excellence.
Comprised of 1,600 faculty, staff,instructors and students, the Duke University School of Nursing along with the Duke University School of Medicine 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.
Develop, coordinate, implement, monitor, and iterate administrative strategies essential to the successful management of complex research & innovation portfolios led by two faculty investigators who are leaders in Data Science, Precision Health, and Health Innovation. Perform and oversee a variety of multifaceted duties involved in supporting the regulatory, licensing, compliance, and business development infrastructure of these portfolios. Frequently interact with research and innovation collaborators and partners across Campus and external entities to facilitate required processes and collaborations. Lead team in problem solving regulatory and compliance issues of moderate to complex scope. Coordinate communication and operational efforts between all relevant stakeholders including the School of Nursing Center for Nursing Research, Business Office, Information Technology Office, other SON leaders and relevant Duke University central offices and schools to ensure successful operation of these programs.
This position exists within the Center for Nursing Research – Clinical Research Unit and reports to the Assistant Dean for Research Development with dotted line reporting to the Assistant Dean for Information Technology and the faculty members leading the portfolios supported by this position.
Program, Project, and Portfolio Management
• Administers and coordinates the activities and infrastructure related to the operation of multiple program portfolios at the School of Nursing, including that of Dr. Xiao Hu and Dr. Ryan Shaw.
• Manages and coordinates operational policies and procedures.
• Develops, composes, and revises Standard Operating Procedures (SOPs) and Data Management Plans (DMPs). Performs quarterly review of DMP in coordination with the program leaders and DUSON leadership.
• Compiles and maintains records, reports and documentation of program portfolio activities.
• Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
• Identifies gaps, constraints, needs, and milestones; helps develop operational plans
• Tracks all aspects of portfolio/program management
• Maintains communication within programs and with other DUSON and Duke departments or offices to accomplish the program objectives and an awareness of regulations, policies, and resources relevant to portfolio; applies knowledge to the development and execution of operational plan.
• Communicates project/program progress with Faculty members and DUSON leadership and adjust plans and timelines according to feedback.
• Represents program or project at internal and external meetings.
• Ensures that institutional communications are shared with research program staff and faculty.
• For complex scenarios, recognizes when all types of agreements are necessary and directs teams to appropriate Duke offices for execution of agreements.
• Maintains study level documentation for all studies, including those that are complex in nature.
• Plans and conducts meetings with collaborators to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.
Data Provenance, Management, Storage and Security
• Works with SON-IT and CNR to develop and implements protocols for research program that include strategies and processes to ensure data security, provenance, and data flow.
• Confers with other staff involved in data collection, data analysis, and the execution of the projects to ensure compliance with protocol guidelines and adherence to requirements.
• Serves as an expert in and oversees the processes of developing data management plans, including data flow, data corrections, queries, quality assurance, data security and provenance.
• Recommends and leads implementation of improved processes, policies, and systems to ensure data security and provenance.
• Identifies problems and/or inconsistencies in data management, security, and storage; recommend corrective action as appropriate and helps teams work through solutions.
• Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for program/portfolio, as relevant.
Leadership and Professionalism
• Keeps current with advances in the scientific area and considers the impact on the research program.
• Keeps self and team current with research updates by attending external offerings.
• Uses advanced subject matter expertise to solve complex problems or foster innovation within the research program.
• Plays a key leadership role on committees and workgroups.
• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• Develops and implements solutions that work within the existing leadership or organizational structure.
• Demonstrates resilience and actively facilitates the research program through change.
• Communicates effectively with others to accomplish shared work objectives.
• Recognizes and escalates organizational issues that could be optimized to improve research process.
• Ensures that studies are conducted in compliance with institutional requirements and other policies.
• May be responsible for summarizing and clarifying for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
• Provides oversight and assistance to research program team members who: develop and submit documentation and information for institutional review and prepare and submit documents needed for regulatory and compliance reporting to DUSON and Duke offices.
• Manages relationships with all program/portfolio stakeholders.
• Performs other related duties incidental to work described herein.
• The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
• A bachelor’s degree in the health and/ data sciences
• 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 experience.
• Experience with program, project, or portfolio management, preferably for research and innovation labs or units
• Experience with regulatory and compliance activities, preferably at a University, Medical Center, or biotech industry
• Experience with contracts and data agreements, preferably at a University
• Experience supporting the advancement of faculty and staff’s early-stage innovations, including commercialization and technology transfer
• Strong commitment to SON core values including diversity, inclusion and equity
• Program and Project Management
• Strong verbal and written communication skills
• Strong organizational, analytical, and problem-solving skills
• An understanding of contracts, agreements, data management plans
• An understanding of early-stage innovation, technology transfer and commercialization
• Familiarity with compliance and regulatory environments at Universities, Medical Centers or Biotechnology companies
• Able to handle management of complex portfolios
• Ability to learn new technologies, processes and policies quickly
• Ability to work independently, multi-task and complete tasks in a fast-paced, highly dynamic work environment
• Proficient in Microsoft Word, Excel and PowerPoint as well as project management tools (e.g., Trello, Smart sheet, Monday.com).
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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.