Research Program Leader

Occupational Summary

Develops, coordinates, and implements research and administrative strategies essential to the successful management of research programs within the Clinical and Translational Science Institute (CTSI), Biostatistics, Epidemiology and Research Design (BERD), the Multiscale Immune Systems Modeling (MISM), and related initiatives. This position supports medium- to large-scale, multi-functional initiatives across multiple affiliated programs, performing and overseeing complex activities related to program implementation, evaluation, and monitoring progress toward program and project milestones. Provide guidance on portfolio and project implementation strategy and assist with efforts to obtain and manage study or program funding. Serves as a primary liaison for research programs and related projects and coordinates activities across faculty, staff, trainees, external collaborators, and partnering institutions. Responsible for program delivery, costs, methods, and reporting requirements.

Work Performed

Program, Project, and Portfolio Management 30%

• Determines short- and long-term goals of research programs and shared resources in collaboration with the BERD Director and other program leads. Identifies program gaps, constraints, needs, and milestones; helps develop operational sustainability plans and communicates resource needs to support program objectives.
• Manages and documents all aspects of the research project lifecycle including initiation, planning, execution, monitoring, and closing. Directs project staff in the execution of project activities in accordance with project plans and timelines and supports the development and implementation of new research and program initiatives.
• Ensures that institutional communications are shared with program staff and faculty. Maintains communication across CTSI programs, departments, partnering institutions, and affiliated networks to accomplish program objectives.
• Manages, mentors, and trains staff, including supporting the transition of newly developed programs to operational teams. Maintains awareness of regulations, policies, and resources relevant to workforce development, translational science, and research administration and applies this knowledge to the development and execution of operational plans.
• Ensures that programs and projects are compliant with applicable regulations and policies. Provide guidance on best practices in research study and program conduct and supports program evaluation and continuous improvement activities.
• Provides intellectual contributions, including developing and editing research proposals and manuscripts. Represents research programs and shared resources on behalf of program leadership at internal and external meetings.
• Coordinates training programs, outreach activities, workshops, and collaborative initiatives in support of CTSI, BERD, and related programs. Lead development and implementation of training programs, including recruitment, application management, interview coordination, and onboarding processes.
• Anticipate, identify and provide resolution to complex problems across multiple concurrent projects and programs, and proactively implement solutions.

Research Operations (30%)

• Serves as an expert resource and provides training regarding memorandums of understanding and agreements, translational science and program development documentation, regulatory and institutional policies and processes, study monitoring, participant retention, recruitment, screening, standard operating procedures (SOPs), and team meeting facilitation.
• Recognizes when agreements are necessary and coordinates with study teams, partnering institutions, and appropriate Duke offices to ensure compliance and program objectives are met. Navigate conversations with foreign agencies, institutions, and study teams to obtain documentation required for compliance with international regulations.
• Collaborates with program leadership to identify high-priority initiatives and develop implementation plans, operational processes, and best practices that support research, workforce development, and translational science programs.
• Develops and oversees strategies for meeting recruitment goals, liaises with Duke resources to optimize retention rates, and supports program evaluation and continuous improvement efforts. Lead outreach activities to spread awareness to recruit participants for new programs.
• Prepares for and facilitates research program meetings in order to achieve objectives. Ensures effective communication within research programs, including mentoring staff to improve communication strategies.
• Develops summary reports, presentations, and briefing materials to support leadership decision-making, strategic planning, and program operations. Collaborates with program leadership and administrative partners to support effective management of program resources, agreements, and operational activities.
• Oversee 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

Safety and Ethics 5%

• 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.
• Prepares and submits documents required for regulatory reporting to sponsors and other agencies and ensures appropriate documentation is maintained in accordance with regulatory and institutional requirements.
• Coordinates with program staff to ensure that program evaluation, research activities, participant documentation, and consent processes are conducted and documented in accordance with approved IRB protocols and regulatory requirements.

Data 10%

• Selects and implements data capture methods appropriate for research, program evaluation, and translational science initiatives. Provides guidance and training related to data management, cleaning, security, provenance, standards, workflow, corrections, queries, quality assurance, and the use of data collection platforms.
• Develops and implements protocols that ensure data security and provenance for research and evaluation activities. Oversees the process of quality assurance (QA), data corrections, and queries, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff.
• Works with program leadership, quantitative scientists, evaluators, and affiliated partners to ensure that data is collected, managed, and shared according to best practices and is aligned with FAIR data and open science principles.
• Predicts areas of data workflow vulnerability and helps staff work through solutions. Ensures that staff are familiar with data workflow resources and best practices and that research and evaluation activities are conducted in accordance with approved protocols.
• Seeks out and applies new technical knowledge toward innovation and performance improvement. Develops reports, dashboards, and visualizations to communicate progress, outcomes, and program impact to leadership, collaborators, and stakeholders.
• Conduct rapid and in-depth qualitative analyses, critically examine and interpret structured, semi-structured, and unstructured data, and explain findings in relation to program, evaluation, and research objectives. Advise others on qualitative data collection, management, and analysis approaches.
• Use statistical tools to prepare and analyze data under the direction of a Biostatistician and program leadership and assist with the development of analysis plans and provide mentorship regarding analytical tools and best practices.

Scientific Concepts 10%

• Independently develops and writes substantial portions of funding proposals and grants and assesses operational challenges and solutions related to proposal development and implementation. Monitors NCATS and other relevant funding agencies to identify funding opportunities aligned with programmatic priorities.
• Reviews and synthesizes scientific and programmatic literature and applies knowledge of research design, translational science, and program evaluation principles to support the development of manuscripts, grant proposals, research protocols, and new program initiatives.
• Contributes to publications, presentations, and other dissemination activities and may provide guidance or mentorship to others in these areas.

Site and Study Management 5%

• Mentors, trains, and oversees activities related to communication with sponsors, collaborators, institutional subaward partners, and other stakeholders; site visits; management of resources (staff, supplies, and equipment); and implementation of operational plans across the research program, including multi-site initiatives.
• Oversees the use of systems and system reports to manage research participant activities, track financial milestones, manage research protocol activities, and maintain current protocol information. Works with grant managers and program leadership to support effective program operations and implementation planning.
• Makes feasibility and implementation recommendations for research programs and works with the Clinical Research Unit (CRU) and departmental leadership to ensure studies and program activities are conducted and closed in accordance with institutional requirements and best practices.

Leadership and Professionalism 10%

• Evaluates and implements departmental, CRU, and division professional development and training initiatives to support staff retention, continuous improvement, and workforce development.
• Keeps current with advances in translational science, biostatistics, informatics, and data science and considers the impact on research and program activities. Applies learned knowledge to improve program operations and keeps team members informed of relevant developments.
• Collaborates with faculty, health system leadership, and program stakeholders to develop project objectives, methodologies, and operational solutions that support scientific and strategic goals. Participates in committees, workgroups, and cross-functional initiatives to advance program priorities.
• Navigates organizational processes and develops effective working relationships with internal and external stakeholders, including faculty, staff, collaborators, sponsors, and partner organizations, to accomplish shared objectives.
• Demonstrates resilience and facilitates research and program activities through change. Uses subject matter expertise to solve complex operational challenges, foster innovation, and support continuous improvement.
• Communicates effectively across reporting relationships and stakeholder groups. Coordinates and facilitates team activities, establishes priorities, and supports the successful execution of program goals and deliverables.

Required Qualifications at this Level

Education

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.

Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).