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RESEARCH PROGRAM LEADER
Job Title: RESEARCH PROGRAM LEADER
Job Code: 1280
FLSA: E
Job Level: 58
Revised Date: 10/13/2025
Job Family: JF 05
Occupational Summary
Develops, coordinates, and implements research and administrative strategies essential to the successful management of research programs led by investigator(s) and faculty. Performs and oversees a variety of complex duties involved in the collection and evaluation of research program data to monitor progress toward program and project milestones. Provides guidance on portfolio and project implementation strategy to provide direction for research activities within the portfolio or program. Assists with efforts to obtain and manage study or program funding. Frequently interacts with other research groups and programs, by serving as primary liaison and public relations lead for research program and related projects. Coordinates wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.
Work Performed
Program, Project, and Portfolio Management
Determines short and long term goals of the research program or shared resource in collaboration with investigator(s). Identifies research programs or shared resources gaps, constraints, needs, and milestones; helps develop operational sustainability plans and communicates with the Principal Investigator (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.
Communicates project and program progress with all major stakeholders and adjust plans and timelines according to feedback.
Manages the research program or shared resource operations. Monitors and adheres to the established budget and assists with budget development.
Ensures that institutional communications are shared with research program staff and faculty. Maintains communication within program and with other departments or offices to accomplish program objectives.
Manages, mentors, and trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plans. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts. Represents research program or shared resource on behalf of the PI at internal and external meetings.
Research Operations
Serves as an expert resource and may provide training to research program team members regarding, contracts and agreements, Investigational New Drug (IND) and Investigational Device Exemption (IDE) documentation, regulatory and institutional policies and processes, investigational products (IP), study monitoring, audit visits, participant and study level documentation, participant retention, recruitment, screening, standard operation procedures (SOPs), specimen handling, study visits, and team meetings.
For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
Assists junior staff to address Food and Drug Administration (FDA) review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA.
May independently navigate conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies.
Oversees the management and documentation of IP for research program. Designs, implements, and optimizes methods for handling IP. Designs, implements, and optimizes methods for handling IP.
Develops and oversees the implementation of strategies for meeting recruitment goals for the research program. Liaises with other resources at Duke to optimize retention rates.
Prepares for and leads effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies.
Safety and Ethics
Serves as an expert resource and may provide training to research program team members who, develop and submit documentation and information for Institutional Review Board (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
Serves as an expert resource and may provide training to research program team members regarding electronic case report forms (ECRFs) and electronic data capture systems (EDCs) design, data management and cleaning, data security and provenance, data standards, common data elements, data workflow, data corrections, data queries, data quality assurance, and return of results.
Selects and implements data capture methods appropriate for the research program.
Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance.
Oversees the process of quality assurance (QA), data corrections, and queries used within the research program, including creating and using QA protocols, queries, summaries and reports. Recognizes trends and recommends strategies to improve processes or retrain staff.
Works with the Clinical Research Unit (CRU) or departmental leadership to ensure that data is shared according to best practices and guidelines and is aligned with FAIR data and open science principles.
Predicts areas of data flow vulnerability. Determines areas where data provenance may be compromised and helps staff work through solutions. Ensures that staff are familiar with data workflow resources at Duke.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for research program, as relevant.
Develops reports on research program progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
May conduct rapid and in depth qualitative analyses and summarizes findings, critically examine and interpret unstructured and semi structured data, and rigorously explain findings in relation to the research context. May serve as the lead qualitative analyst on projects and advise other analysts on how to use a variety of available tools and software to code and categorize qualitative data. May lead in the development of qualitative data analysis plans that align with study objectives and provide mentorship or education to others regarding best practices for qualitative analyses.
May use statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis on a variety of data formats and code data using statistical tools to prepare for analysis under direct supervision from Biostatistician and PI. May create statistical analysis plans and provides mentorship and education for various tools used for statistical analysis.
Scientific Concepts
Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals.
Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
Independently develops protocols for multiple complex investigator initiated studies within the research program.
Uses expertise in research design to provide significant contribution to protocols or research proposals.
Provides significant contribution or leadership on accepted, peer reviewed publications or conference presentations. Mentors others in this area.
Site and Study Management
Mentors, trains, and oversees activities related to how teams communicate with sponsors and contract research organizations (CROs), site visits, management of resources (staff, supplies, equipment) and implementation of operational plans across the research program (including at multiple sites); and use of systems and system reports to manage research participants activities, track and mark financial milestones, manage research protocol activities, and maintain current protocol information.
Makes feasibility recommendations for research program. Develops and oversees processes to determine participation in trials. May manage the budget for research studies.
Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with and closed according to institutional requirements and best practices.
Leadership and Professionalism
Evaluates and implements the department, CRU, or division professional development and training programs to ensure they meet the needs of staff retention, continuous improvement, and development.
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; applies learned material
Required Qualifications at this Level
Education/Training
Completion of a Bachelor's degree
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).
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.
Duke University is an 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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 essential job 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.
