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.

Position is only open to applicants that do not require sponsorship for employment visa status or will not require renewal (e.g. H-18, TN, J-1, OPT)

Occupational Summary

The Center for Virtual Imaging Trials is seeking a candidate to fill the position of Research Program Leader. The broad objective of the Center for Virtual Imaging Trials is to develop and provide a comprehensive virtual platform to assess the clinical performance of medical imaging technologies or applications from design to use. In its first phase, the Center focuses on Computed Tomography (CT). The Center will provide essential resources to optimize the design and use of CT technologies for improved human health.

This individual reports to the Center’s PI and works alongside the Center’s PI and Executive Committee to administer the Center, providing logistical and organizational management of the Center’s activities and data.

The activities include:

• Facilitating day-to-day communication, coordination, and integration across Center
• Instituting a communication log and tracking and follow up on all communications with CPs and SPs using the communication log
• Initiating a project tracking system and tracking and follow up on all Center tasks and associated data using the project tracking system
• Proactively identifying obstacles as they arise
• Meeting planning and action follow-ups – including EC, IAC, and EAC meetings
• Supporting, scheduling, and organizing training activities
• Providing editorial and technical assistance with document preparation, including the Center’s annual Progress Reports
• Requesting and managing from each resource user the following information annually: an update on how the resource has contributed to the person’s research, any related grant funding or publication achieved, and any suggestions for improvements or future developmental work. This communication will also remind each of the appropriate acknowledgement for any future publications or conference presentations

The duties of the position include the following:

• Develop, coordinate, and implement research and administrative strategies essential to the successful management of research programs led by investigator(s) and faculty.
• Perform and/or oversee a variety of complex duties involved in the collection and evaluation of research program data to monitor progress toward program and project milestones.
• Provide guidance on portfolio/project implementation strategy to provide direction for research activities within the portfolio or program. Assist with efforts to obtain and manage study or program funding.
• Frequently interact with other research groups or programs, by serving as primary liaison and public relations lead for research program and related projects.
• Coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements

• Program, Project, and Portfolio Management
• In collaboration with the Center Leaders, sets and defines measures for short and long term goals of the research program/shared resource. Identifies gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing.
• Manages and documents all aspects of research project lifecycle including: initiation, planning, executing, monitoring, and closing.
• Directs project staff in the execution of project activities in accordance with project plan and timeline.
• Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts.
• Manages the research program or shared resource operations.
• Monitors and adheres to the established budget, and assists with budget development

• Additional responsibilities
• Research Operations: Serves as an expert resource and may provide training to research program team members regarding, regulatory and institutional policies and processes, screening, recruitment, retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND/IDE documentation, investigational product, and contracts and agreements.
• Safety and Ethics: Provides oversight and training to research program team members who: develop and submit documentation and information for IRB review, prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies, identify and document adverse event information, conduct, document, and develop consent for participants for all types of studies.
• Data: Selects and implements data capture methods appropriate for the research program. Serves as an expert in and oversees the processes of designing ECRFs and EDCs, data flow, data corrections, queries, quality assurance, data security and provenance. Recognizes trends, and recommends strategies to improve processes or retrain staff. Develops and implements protocols for research program that include strategies and processes to ensure data security, provenance, and data flow.
• Scientific Concepts: Independently writes and edits substantial portions of funding proposals and grants, develops protocols for multiple complex investigator- initiated studies within the research program, and synthesizes literature to assist in the development of manuscripts or grant proposals. Uses expertise in research design to provide significant contribution to protocols or research proposals.
• Site and Study Management: Makes feasibility recommendations for research program. Develops and oversees processes to determine participation in trials. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies.

Perform other related duties incidental to the 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.

Education/Training:

Work requires a minimum of a Bachelor’s degree. A Master’s or doctoral degree in a scientific discipline (eg, medical physics, BME, computer science, etc) will be highly preferred.

Experience:

Work 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 the electronic medical record).

** Prior experience in related scientific activities and management is highly encouraged.

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

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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.