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RESEARCH PROGRAM LEADER, SR
Job Title: RESEARCH PROGRAM LEADER, SR
Job Code: 1281
FLSA: E
Job Level: 69
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
Leads the development, implementation, and oversight of major research program(s) and shared resource(s) led by investigator(s) and faculty; Performs and and or oversees a variety of complex duties involved in the analysis, interpretation, and communication of data related to program and project milestones. Leads content and direction of major research program(s) and shared resources(s). Leads and reports on efforts to obtain and manage study or program funding. Frequently leads communications with other research groups or programs, serving as primary liaison and public relations lead for the research program. Develops and coordinates wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.
Work Performed
Program Management and Project Development
Develops strategies to improve or maintain the effectiveness of the research program and shared resource. Engages large groups of diverse stakeholders and facilitates the development of actionable plans and measurable outcome goals. Manages progress of collaborating stakeholders toward achieving project and program goals. Establishes risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and direct staff in execution of plans.
Provides overall leadership of large research program and shared resource provides guidance and mentorship as an operational subject matter expert to others who develop or manage large research programs or studies. Develops, negotiates, and oversees budgets. Allocates and forecasts resources. Oversees, supervises, or mentors staff who manage the day-to-day operations. Provides guidance to faculty investigators, divisional or Duke office leaders on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
Provides significant intellectual contribution to the research program and shared resource, including substantial leadership in developing the scientific content of research proposals and manuscripts. Establishes and maintains internal (Duke) and external communications to ensure successful research partnerships. Suggests hypotheses, research strategies, research partnerships, and research opportunities.
Frequently represents research program or shared resource on behalf of the PI.
Research Operations
Works with institutional leaders and offices to handle complex issues related to contracts and agreements. Helps the research program resolve complicated contractual problems.
Participates in or leads the development of institutional policies and guidance documents about managing investigational product (IP).
Participates in or leads development of monitoring and audit training sessions and and or policies and guidelines for research program.
Develops, oversees adherence, and trains research portfolio team members in regulatory and institutional policies and processes, screening, recruitment, retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND and IDE documentation, investigational products, and contracts and agreements.
May provide input for institutional SOPs and serve as an expert resource across all study teams within the research program (s) and shared resources(s) for navigating regulatory compliance with international studies.
Safety and Ethics
Serves as an expert resource and is knowledgeable about other resources at Duke pertaining to: developing and submitting documentation and information for IRB review, preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, identifying and documenting adverse event information, conducting, documenting, and developing consent for participants for all types of studies.
Data
Under direct supervision from Biostatistician and PI may perform analyses on a variety of data formats and create data analysis plans.
Serves as an institutional expert resource for various tools used for analysis and data management. Mentors others on analysis as appropriate to their role.
Serves as an institutional resource on ECRFs, EDCSs, technologies, and software to ensure the highest quality data collection and capture. Actively encourages connections with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB).
Coordinates with institutional leadership on initiatives and priority setting to ensure appropriate QA processes and development of data provenance and security training sessions, guidelines, and policies.
Serves as an expert in data sharing and data standards, including advising on appropriate standards for the types of research included in their portfolio and liaising with and being knowledgeable about other resources at Duke, and regulations and best practices.
Predicts areas of vulnerability in data flow across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Ensures that study teams are familiar with and using data flow plan resources at Duke.
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement, as relevant. Ensures continuous evaluation of technology solutions throughout the research portfolio.
Oversees implementation of data quality processes, data flow plans, and new technologies across research portfolio.
Scientific Concepts
Independently writes and edits significant sections of funding proposals and grants, reviews articles, synthesizes the literature, and develops manuscripts.
Provides significant contribution or leadership on multiple accepted, peer reviewed publications or conference presentations.
Uses expertise in research design to develop protocols or research proposals.
Serves as an expert resource to faculty, trainees, and staff for the development of protocols for complex investigator-initiated studies and research design.
Site and Study Management
Oversees the research resources and and or finance processes for a broad research portfolio. Works with central offices to optimize process.
Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies.
Oversees implementation of how teams communicate with sponsors and CROs, site visits, management of resources (staff, supplies, equipment), implementation of operational plans, and use of systems and system reports across multiple research program(s) and shared resources (s).
Leadership and Professionalism
Keeps current with research updates and advances in the scientific area, considers the impact on the broad research portfolio, and oversees necessary implementation. Serves in a leadership capacity with internal and external groups (e.g., speaks at events, leads institutional initiatives or committees).
May develop and implement solutions at the institutional level to improve the research process. Uses expertise and acumen to influence change at the division, department, or CRU level.
Demonstrates resilience, leadership, and actively facilitates change for research program(s) and shared resources(s).
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research portfolio.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns activities of other managers to accomplish goals of the broad research portfolio. Uses expertise in research design to develop protocols or research proposals.
Serves as an expert resource to faculty, trainees, and staff for the development of protocols for complex investigator-initiated studies.
May serve as an institutional expert with regard to research design. 6. Site and Study Management.
Oversees the research resources and/or finance processes for a broad research portfolio.
Works with central offices to optimize process.
Makes feasibility recommendations for research program.
Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies.
Oversees implementation of how teams communicate with sponsors and/or CROs, site visits, management of resources (staff, supplies, equipment), implementation of operational plans, and use of systems and system reports across multiple research program(s)/shared resources(s).
Leadership and Professionalism.
Keeps current with research updates and advances in the scientific area, considers the impact on the broad research portfolio, and oversees necessary implementation.
Serves in a leadership capacity with internal and external groups (e.g., speaks at events, leads institutional initiatives or committees).
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research program(s)/shared resources(s).
May develop and implement solutions at the institutional level to improve the research process.
Uses expertise and acumen to influence ch
Required Qualifications at this Level
Education/Training
Completion of a Bachelor's degree
Experience
Work requires a minimum of eight 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 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 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.
